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.

Active Ingredient

Acetaminophen 500 mg Diphenhydramine HCI 25 mg

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


Structured Label Content

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.

Active Ingredient (55106-9)

Acetaminophen 500 mg Diphenhydramine HCI 25 mg

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

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


Raw Label Data

All Sections (JSON)