Care One Sleep Aid

Doxylamine succinate 25 mg

Nighttime sleep-aid

Ask a doctor before use if you have

• a breathing problem such as asthma, emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

Do not give

to children under 12 years of age

Ask a doctor or pharmacist before use if you are

taking any other drugs

When using this product

• avoid alcoholic beverages
• take only at bedtime

Stop use and ask a doctor if

• sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

• store at 68°-77°F (20°-25°C)
• retain in carton until time of use
• see carton end panel for lot number and expiration date

Applies to doxylamine: compounding powder, oral tablet, oral tablet chewable

General

Most side effects are mild and short-lived; serious side effects are rare.[Ref]

Musculoskeletal

Frequency not reported: Muscle weakness[Ref]

Nervous system

Frequency not reported: Sedation, dizziness, impaired coordination, paradoxical excitation, drowsiness, headache, anticholinergic effects (e.g., dry mouth, nose, and/or throat)[Ref]

Respiratory

Frequency not reported: Thicker nasal discharge[Ref]

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

Use should be avoided during breastfeeding or if planning to breastfeed. Excreted into human milk: Yes Comments: Small occasional doses of this drug would not be expected to cause any adverse effects in breastfed infants; however, larger doses or more prolonged use may cause drowsiness, unusual excitement, or irritability in nursing infants and/or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established.

-In one telephone follow-up study, irritability and colicky symptoms were reported in 10% and drowsiness was reported in 1.6% of infants exposed to various antihistamines; none of the reactions required medical attention. -Relatively high doses of antihistamines given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women; however, it is unknown whether lower oral doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success.