Extra Strength
8c9f68e3-fedc-6457-e053-2995a90a045a
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
(in each caplet) Acetaminophen, USP 500mg Diphenhydramine HCl. 25mg
Purpose
Pain reliever Nighttime sleep-aid
Medication Information
Purpose
Pain reliever Nighttime sleep-aid
Description
(in each caplet) Acetaminophen, USP 500mg Diphenhydramine HCl. 25mg
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Purposes
Pain reliever
Nighttime sleep-aid
Directions
■ do not take more than directed (see overdose warning)
adults andchildren 12 years and over
■ take 2 caplets at bedtime do not use
■ do not take more than 2 caplets of this product in 24 hours
children under 12 years
■ do not use
Dso Not Use
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist
■ with any other product containing diphenhydramine, even one used on skin
■ in children under 12 years of age
■ if you have ever had an allergic reaction to this product or any of its ingredients
Allergy Alert
acetaminophen may cause severs skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away
Liver Warning
This product containsacetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while
using this product
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Information
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see end panel for expiration date and lot number
Active Ingridients
(in each caplet)
Acetaminophen, USP 500mg
Diphenhydramine HCl. 25mg
Inactive Ingridients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone,pregelatinized starch, stearic acid, titanium dioxide
Principal Display Panel
When Using This Product
■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery
Stop Use and Ask A Doctor If
■ sleeplessness persists continuously for morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
■ pain gets worse or lasts more t han 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition.
If Pregnant Or Breast Feeding
ask a health professional before use.
Ask A Doctor Before Use If You Have
■ liver disease
■ a breathing problem such as emphysema or chronic brochitis
■ trouble urinating due to an enlarged prostate gland
■ glaucoma
Ask A Doctor Or Pharmacist Before Use If You Have
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
Structured Label Content
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Purposes
Pain reliever
Nighttime sleep-aid
Directions
■ do not take more than directed (see overdose warning)
adults andchildren 12 years and over
■ take 2 caplets at bedtime do not use
■ do not take more than 2 caplets of this product in 24 hours
children under 12 years
■ do not use
Dso Not Use (DSo not use)
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist
■ with any other product containing diphenhydramine, even one used on skin
■ in children under 12 years of age
■ if you have ever had an allergic reaction to this product or any of its ingredients
Allergy Alert (Allergy alert)
acetaminophen may cause severs skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away
Liver Warning (Liver warning)
This product containsacetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while
using this product
Overdose Warning (Overdose warning)
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Information (Other information)
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see end panel for expiration date and lot number
Active Ingridients (Active ingridients)
(in each caplet)
Acetaminophen, USP 500mg
Diphenhydramine HCl. 25mg
Inactive Ingridients (Inactive ingridients)
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone,pregelatinized starch, stearic acid, titanium dioxide
Principal Display Panel
When Using This Product (When using this product)
■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
■ sleeplessness persists continuously for morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
■ pain gets worse or lasts more t han 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition.
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)
ask a health professional before use.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
■ liver disease
■ a breathing problem such as emphysema or chronic brochitis
■ trouble urinating due to an enlarged prostate gland
■ glaucoma
Ask A Doctor Or Pharmacist Before Use If You Have (Ask a doctor or pharmacist before use if you have)
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:51.595496 · Updated: 2026-03-14T23:11:47.306350