Other
Drug Facts
Distributed by:
Walgreen Co.
200 Wilmot Rd., Deerfield, IL 60015
The following Structured Product Label (SPL) was submitted to the FDA by Gobrands, Inc for the product Extra Strength Pain Reliever Pm (NDC 82501-1587). 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, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by:
Walgreen Co.
200 Wilmot Rd., Deerfield, IL 60015
| 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
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist in children under 12 years of age with any other products containing diphenhydramine, even one used on skin if you are allergic to acetaminophen or any of the inactive ingredients in this product
drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery.
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 directed 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.
(see Overdose warning)
| adults and children 12 years of age and over: |
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| children under 12 years of age: |
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each caplet contains: magnesium 0.05 mg store between 20°-25°C (68°-77°F) see end panel for lot number and expiration
FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone, pregelatinized starch, stearic acid, titanium dioxide
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