Allfen CD

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Codeine and guaifenesin is a combination medicine used to treat cough and chest congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine and guaifenesin may also be used for purposes not listed in this medication guide.

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Ask a doctor before giving this medicine to a child younger than 12 years old. Do not give this medicine to anyone under 18 who recently had surgery to remove the tonsils or adenoids.

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other cough or cold medicine. Many combination medicines contain guaifensin. Taking certain products together can cause you to get too much of this medicine.

Taking codeine and guaifenesin with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with codeine and guaifenesin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

In the U.S.

• Ala-Hist AC
• Ala-Hist DHC
• Alavert-D 12-Hour
• Aldex D
• Alka-Seltzer Plus Cold and Sinus
• AllanVan-S
• Allegra-D
• Aller-Chlor
• Allerx-D
• Allfen CD
• Allres PD
• Amibid LA
• Benadryl
• BPM Pseudo
• Bromcomp HC
• Bromfed-PD
• BroveX CB
• By-Ache
• Canges-HC
• Ceron
• Ceron-DM
• Chlor-Trimeton Nasal Decongestant
• Clarinex-D
• Codimal DH
• Cotab A
• Cotabflu
• Cypex-LA
• Deconamine SR
• Delsym
• Dexphen w/C
• Donatussin DC
• Donnatussin
• D-Tann HC
• EndaCof-DC
• FluTuss XP
• Genapap Sinus
• G Phen DM
• HC Tussive
• Histex PD
• Humibid DM
• Hycodan
• Hycofenix
• Hydone
• HyTan
• Kie
• Levall 12
• Lusonal
• Maxiflu CD
• Maxiphen CD
• M-End Max D
• Mucinex D
• Nasop
• Notuss-Forte
• Notuss-NX
• Notuss-NXD
• Novahistine DH
• Pancof HC
• Pediatex 12
• Pediatex 12D
• Pediatex 12DM
• Pediatex-D
• Phenergan w/Codeine
• Phenflu CD
• Phenylephrine CM
• Phenylhistine
• Poly-Tussin AC
• Poly-Tussin DHC
• Pro-Clear AC
• Promethazine VC With Codeine
• Pro-Red AC
• RelaTuss HC
• Robitussin
• Robitussin DM
• Ryneze
• Semprex-D
• SSKI
• Stahist
• Sudafed
• SymTan
• SymTan A
• Tanafed DMX
• Tannate Pediatric
• Tessalon Perles
• Tricold Pediatric Drops
• Tripohist D
• Tussi-12 S
• TussiCaps
• Tuzistra XR
• Tylenol
• Uni-Tann D
• Vituz
• Xpect-PE
• Y-Cof DM
• Z-COF DM
• Zhist
• Zodryl DAC 25
• Zotex-D
• Zymine
• Zymine HC
• ZyrTEC-D

In Canada

• Actifed A
• Actifed Plus
• Actifed Plus Extra Strength
• Actifed Plus Head Cold And Sinus Extra Strength
• Actifed Sinus Regular
• Adult Nighttime Cold/Flu Relief - Cherry Flavor
• Adult Nighttime Cold/Flu Relief - Original Flavor
• Allergy Sinus Medication Extra Strength
• Atoma Night Adult Cold/Flu Relief
• Balminil
• Balminil Dm Children
• Balminil Dm Sugar-Free

Available Dosage Forms:

• Suspension
• Tablet, Disintegrating
• Tablet, Chewable
• Solution
• Tablet
• Syrup
• Suspension, Extended Release
• Tablet, Extended Release
• Elixir
• Liquid
• Capsule, Extended Release
• Capsule
• Capsule, Liquid Filled
• Capsule, Extended Release, 12 HR
• Packet
• Tablet, Extended Release, 12 HR
• Film
• Tablet, Effervescent
• Powder for Suspension
• Powder for Solution
• Kit
• Tablet, Extended Release, 24 HR
• Capsule, Extended Release, 24 HR
• Tablet, Enteric Coated

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken, it is taken in large doses, or it is taken for a long period of time.

Get emergency help immediately if any of the following symptoms of overdose occur:

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Cold, clammy skin
• confusion (severe)
• convulsions (seizures)
• drowsiness or dizziness (severe)
• nervousness or restlessness (severe)
• pinpoint pupils of eyes
• slow heartbeat
• slow or troubled breathing
• Difficulty breathing
• difficulty nursing
• increased sleepiness (more than usual)
• limpness

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling or tenderness in the upper abdomen or stomach area

• Any loss of hearing
• bloody urine
• confusion
• convulsions (seizures)
• dizziness or lightheadedness
• drowsiness (severe)
• excitement or nervousness (severe)
• fast or deep breathing
• fever
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased sweating
• nausea or vomiting (severe or continuing)
• shortness of breath or troubled breathing (for salicylamide only)
• stomach pain (severe or continuing)
• uncontrollable flapping movements of the hands, especially in elderly patients
• unusual thirst
• vision problems

• Fast, pounding, or irregular heartbeat
• headache (continuing and severe)
• nausea or vomiting (severe)
• nervousness or restlessness (severe)
• shortness of breath or troubled breathing (severe or continuing)

Check with your doctor as soon as possible if any of the following side effects occur:

• Skin rash, hives, and/or itching

• Clumsiness or unsteadiness
• convulsions (seizures
• drowsiness (severe)
• dryness of mouth, nose, or throat (severe)
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• restlessness (severe)
• shortness of breath or troubled breathing
• slow or fast heartbeat

• Headache (continuing)
• increased watering of mouth
• loss of appetite
• metallic taste
• skin rash, hives, or redness
• sore throat
• swelling of face, lips, or eyelids

• Unexplained sore throat and fever
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• decreased sweating
• difficult or painful urination
• dizziness or lightheadedness
• drowsiness
• dryness of mouth, nose, or throat
• false sense of well-being
• increased sensitivity of skin to sun
• nausea or vomiting
• nightmares
• stomach pain
• thickening of mucus
• trouble in sleeping
• unusual excitement, nervousness, restlessness, or irritability
• unusual tiredness or weakness

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Feeling very sleepy.
• Feeling confused.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Seizures.
• Very bad belly pain.
• Very bad headache.
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Very hard stools (constipation).
• Feeling very tired or weak.

Applies to codeine / guaifenesin: oral capsule, oral liquid, oral syrup, oral tablet

General

The more commonly reported adverse effects of codeine include nausea, vomiting, and diarrhea. Guaifenesin is generally well tolerated.

Nervous system

Codeine
Frequency not reported: CNS depression, lightheadedness, dizziness, sedation, headache, convulsions, weakness[Ref]

Cardiovascular

Codeine
Frequency not reported: Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension, circulatory depression

Gastrointestinal

Codeine
Frequency not reported: Nausea, vomiting, constipation, biliary tract spasm, increased colonic motility, toxic dilation

Guaifenesin:
Frequency not reported: Abdominal pain (upper), diarrhea, nausea, vomiting[Ref]

Genitourinary

Codeine
Frequency not reported: Oliguria, urinary retention, antidiuretic effect[Ref]

Dermatologic

Codeine-induced rash may be related to direct stimulation of histamine release.[Ref]

Codeine:
Frequency not reported: Rash

Guaifenesin:
Frequency not reported: Rash[Ref]

Hypersensitivity

Codeine
Frequency not reported: Pruritus, giant urticaria, angioneurotic edema, laryngeal edema

Guaifenesin:
Frequency not reported: Hypersensitivity reactions (pruritus, urticaria)

Ocular

Codeine
Frequency not reported: Visual disturbances

Psychiatric

Codeine
Frequency not reported: Euphoria, dysphoria, transient hallucination, disorientation

Respiratory

Codeine:
Frequency not reported: Respiratory depression[Ref]

Respiratory depression and death have occurred in children who received codeine in the postoperative period following tonsillectomy and/or adenoidectomy. Further investigation has shown these patients to be ultra-rapid metabolizers of codeine. Children with obstructive sleep apnea who are treated with codeine appear to be particularly sensitive to the respiratory depressant effects of codeine.[Ref]

Some side effects of Allfen CD may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Less than 12 years of age: Not Recommended

12 years or older:
1 dose orally every 4 to 6 hours as needed
-Codeine: Single dose: up to 20 mg; Maximum dose: 120 mg in 24 hours
-Guaifenesin: Single dose: up to 400 mg; Maximum dose: 2400 mg in 24 hours
Maximum dose should not exceed maximum dose of either of the single ingredient doses

Comments:
-Liquid preparations should be measured with an accurate milliliter measuring device.
-Codeine should not be used in adolescents who are obese or have conditions such as sleep apnea or severe lung disease which may increase the risk of serious breathing problems.

Uses: Temporary relief of coughs due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants; helps loosen phlegm and thin bronchial secretions to make cough more productive.

Data not available