good remedies
2d642d8e-c154-a970-e063-6294a90a03bf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Pain reliever Nighttime sleep aid
Description
Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Medication Information
Warnings
Liver warning: this product contains acetaminophen. 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
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Do 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
Ask a doctor before use if you have
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland • glaucoma
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
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 more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
• pain gets worse or lasts more than 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.
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose
Pain reliever
Nighttime sleep aid
Directions
• do not take more than directed (see overdose warning)
| adults and children 12 years and over | • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours |
| children under 12 years | do not use |
Other Information
• store at room temperature between 20°-25°C(68°-77°F)
• protect from light, heat and moisture
Inactive Ingredients
FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone, pregelatinized starch, stearic acid powder, titanium dioxide
Description
Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Section 42229-5
Compare to the active ingredients of Extra Strength Tylenol® PM*
Distributed by:
Strive Pharmaceuticals Inc.,
East Brunswick, NJ 08816
PRODUCT OF INDIA
*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Tylenol®.
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Section 50565-1
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Packaging
Drug Facts
Active Ingredients
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Questions Or Comments?
1-888-577-8033 Monday - Friday 8am - 4pm EST
Structured Label Content
Warnings
Liver warning: this product contains acetaminophen. 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
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Do 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
Ask a doctor before use if you have
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland • glaucoma
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
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 more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
• pain gets worse or lasts more than 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.
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose
Pain reliever
Nighttime sleep aid
Directions
• do not take more than directed (see overdose warning)
| adults and children 12 years and over | • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours |
| children under 12 years | do not use |
Other Information (Other information)
• store at room temperature between 20°-25°C(68°-77°F)
• protect from light, heat and moisture
Inactive Ingredients (Inactive ingredients)
FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone, pregelatinized starch, stearic acid powder, titanium dioxide
Section 42229-5 (42229-5)
Compare to the active ingredients of Extra Strength Tylenol® PM*
Distributed by:
Strive Pharmaceuticals Inc.,
East Brunswick, NJ 08816
PRODUCT OF INDIA
*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Tylenol®.
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Section 50565-1 (50565-1)
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Packaging
Drug Facts
Active Ingredients (Active ingredients )
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Questions Or Comments? (Questions or comments?)
1-888-577-8033 Monday - Friday 8am - 4pm EST
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:44.818120 · Updated: 2026-03-14T23:08:02.764471