TussiCaps

• ECR Pharmaceuticals Co., Inc.

• Mallinckrodt, Inc.

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

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

Chlorpheniramine and hydrocodone is a combination medicine used to treat runny nose, sneezing, itching, watery eyes, and cough caused by allergies, the common cold, or the flu.

Chlorpheniramine and hydrocodone may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Hydrocodone can slow or stop your breathing. Never use chlorpheniramine and hydrocodone in larger amounts, or for longer than prescribed.

Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away the medicine is against the law.

You should not use antihistamine medication to make a child sleepy.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Shake the oral suspension well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not mix the oral suspension with any other liquids or medicines.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

If you need surgery, tell the surgeon ahead of time that you are using chlorpheniramine and hydrocodone. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Do not allow the liquid to freeze.

Keep track of your medicine. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

• It is used to relieve coughing.
• It is used to ease allergy signs.
• It is used to ease cold signs.

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.
• 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.
• Feeling very tired or weak.
• Very hard stools (constipation).
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Feeling very sleepy.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.

Gastrointestinal Disorders

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of TussiCaps® extended-release capsules may produce constipation.

General Disorders and Administration Site Conditions

Death

Nervous System Disorders

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes.

Renal and Urinary Disorders

Ureteral spasm, spasm of vesical sphincters, and urinary retention have been reported with opiates.

Respiratory, Thoracic and Mediastinal Disorders

Dryness of the pharynx, occasional tightness of the chest, and respiratory depression (see  CONTRAINDICATIONS).

TussiCaps® extended-release capsules may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see  OVERDOSAGE). Use of TussiCaps® in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with TussiCaps® extended-release capsules in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.

Skin and Subcutaneous Tissue Disorders

Rash, pruritus.

Full-Strength: 10 mg/8 mg

TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules

Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “M ” on the cap and “HP/CP” over “10/8” on the body.

Bottles of 20 . . . . . . . . . . . . . . . NDC 0095-0108-20

Bottles of 100 . . . . . . . . . . . . . . NDC 0095-0108-01

Half-Strength: 5 mg/4 mg

TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules

Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with “M ” on the cap and “HP/CP” over “5/4” on the body.

Bottles of 20 . . . . . . . . . . . . . . . NDC 0095-0054-20

Bottles of 100 . . . . . . . . . . . . . . NDC 0095-0054-01

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a well-closed container.

A Schedule CIII Narcotic.

For Medical Information or to report adverse events

Phone: 800-527-1955

Manufactured for:
ECR Pharmaceuticals
Richmond, Virginia
23255

Manufactured by:
Mallinckrodt Inc.
Hazelwood, Missouri
63042 U.S.A.

ECR Pharmaceuticals Logo, TussiCaps and “M” are trademarks of ECR Pharmaceuticals or an affiliate.

© 2011 ECR Pharmaceuticals or an affiliate. All rights reserved.

MG #31369 Rev 10/2011

10 mg/8 mg (full-strength)

10 mg/8 mg (full-strength)

10 mg/8 mg (full-strength)

 NDC 0095-0108-01                                                     100 CAPSULES

TussiCaps®

(Hydrocodone Polistirex and
Chlorpheniramine Polistirex)
Extended-Release Capsules

10 mg/8 mg
(full-strength)          Rx only

Contraindicated in children under 6 years of age.

Each capsule contains:
Hydrocodone Polisitrex equivalent to 10 mg
            hydrocodone bitartrate

Chlorpheniramine Polisitrex equivalent to 8 mg
            chlorpheniramine maleate

This package is not for household use.

USUAL DOSAGE: Adults and Children 12 Years and Older: One (1) full-strength capsule every 12 hours; do not exceed 2 capsules in 24 hours. Not recommended for children under 12 years of age.

INDICATIONS: See package insert.

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a well-closed container.

Do not accept if seal over bottle opening is broken or missing.

Manufactured for:
ECR Pharmaceuticals
Richmond, Virginia 23255

Manufactured by:
Mallinckrodt Inc.
Hazelwood, Missouri 63042 U.S.A.

5 mg/4 mg (half-strength)

5 mg/4 mg (half-strength)

5 mg/4 mg (half-strength)

 NDC 0095-0054-01                                                     100 CAPSULES

TussiCaps®

(Hydrocodone Polistirex and
Chlorpheniramine Polistirex)
Extended-Release Capsules

5 mg/4 mg
(half-strength)          Rx only

Contraindicated in children under 6 years of age.

Each capsule contains:
Hydrocodone Polisitrex equivalent to 5 mg
            hydrocodone bitartrate

Chlorpheniramine Polisitrex equivalent to 4 mg
            chlorpheniramine maleate

This package is not for household use.

USUAL DOSAGE: Adults and Children 12 Years and Older: One (1) full-strength capsule every 12 hours; do not exceed 2 capsules in 24 hours. Not recommended for children under 12 years of age.

INDICATIONS: See package insert.

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a well-closed container.

Do not accept if seal over bottle opening is broken or missing.

Manufactured for:
ECR Pharmaceuticals
Richmond, Virginia 23255

Manufactured by:
Mallinckrodt Inc.
Hazelwood, Missouri 63042 U.S.A.

Applies to chlorpheniramine / hydrocodone: oral capsule extended release, oral suspension extended release

Other dosage forms:

• oral liquid, oral solution

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

Check with your doctor immediately if any of the following side effects occur while taking chlorpheniramine / hydrocodone:

• Decrease in frequency of urination
• decrease in urine volume
• difficult, painful, or troubled breathing
• difficulty in passing urine (dribbling)
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• tightness in the chest

Some side effects of chlorpheniramine / hydrocodone 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:

• Drowsiness
• false or unusual sense of well-being
• fear or nervousness
• itching skin or rash
• nausea
• sleepiness
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting