Package Label
e5f93e73-9e1e-150a-e053-2995a90a2778
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500 mg Diphenhydramine HCI 25 mg
Medication Information
Warnings and Precautions
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 • glaucoma • difficulty urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin • sedatives or tranquilizers When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.
Indications and Usage
for the temporary relief of occasional headaches and minor ache and pains along with accompanying sleeplessness
Dosage and Administration
• 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
Description
Acetaminophen 500 mg Diphenhydramine HCI 25 mg
Section 44425-7
• store at controlled room temperature 20-25 °C (68-77° F)
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. (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.
Section 51727-6
cellulose, croscarmellose sodium, FD & C blue #1 lake, FD & C blue #2 lake, hypromellose, magnesium stearate, PEG, polyvinyl alcohol, povidone, purified water, silicon dioxide, sodium starch glycolate, starch, talc, titanium dioxide
Section 51945-4
1
Section 53413-1
1-800-540-3765
Section 55105-1
Pain Reliever Sleep aid
Section 55106-9
Acetaminophen 500 mg Diphenhydramine HCI 25 mg
Structured Label Content
Indications and Usage (34067-9)
for the temporary relief of occasional headaches and minor ache and pains along with accompanying sleeplessness
Dosage and Administration (34068-7)
• 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
Warnings and Precautions (34071-1)
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 • glaucoma • difficulty urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin • sedatives or tranquilizers When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.
Section 44425-7 (44425-7)
• store at controlled room temperature 20-25 °C (68-77° F)
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. (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.
Section 51727-6 (51727-6)
cellulose, croscarmellose sodium, FD & C blue #1 lake, FD & C blue #2 lake, hypromellose, magnesium stearate, PEG, polyvinyl alcohol, povidone, purified water, silicon dioxide, sodium starch glycolate, starch, talc, titanium dioxide
Section 51945-4 (51945-4)
1
Section 53413-1 (53413-1)
1-800-540-3765
Section 55105-1 (55105-1)
Pain Reliever Sleep aid
Section 55106-9 (55106-9)
Acetaminophen 500 mg Diphenhydramine HCI 25 mg
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:02.583037 · Updated: 2026-02-15T12:07:02.495409