Other
Drug Facts
Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716
The following Structured Product Label (SPL) was submitted to the FDA by Walmart Stores Inc for the product Acetaminophen And Diphenhydramine Hydrochloride (NDC 49035-026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 500mg | Pain reliever |
| Diphenhydramine HCl 25mg | Nighttime Sleep aid |
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
This product contains acetaminophen. Severe liver damage may occur with this product if you take
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| adults and children 12 years of age and over: |
|
| children under 12 years of age: |
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FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide
1-888-287-1915
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