Package Label

Package Label
SPL v5
SPL
SPL Set ID e5f93e73-9e1e-150a-e053-2995a90a2778
Route
ORAL
Published
Effective Date 2013-05-27
Document Type 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)