Pain Reliever And Sleep Aid

Pain Reliever And Sleep Aid
SPL v4
SPL
SPL Set ID ba43b809-66fb-4368-a2f6-1e53e4020b7e
Route
ORAL
Published
Effective Date 2022-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Blue No. 2 Hypromelloses Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Starch, Corn Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S26 Shape: capsule Color: blue Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-17

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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.

Directions

do not take more than directed (see overdose warning)

adults & children 12 years & over • take 2 tablets at bedtime

• do not take more than 2 tablets of this product in 24 hours
children under 12 years do not use

Drug Facts

Do Not Use:

• with 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

Distributed By:

Cabinet Health P.B.C.

Other Information

• store between 20–25°C (68–77°F)

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.

Inactive Ingredients

FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

1-888-333-9792

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 more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness • pain gets worse or lasts for 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.

Keep Out of Reach of Children.

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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 If You Are

• 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

Purpose

Pain reliever

Nighttime sleep aid

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.

Directions

do not take more than directed (see overdose warning)

adults & children 12 years & over • take 2 tablets at bedtime

• do not take more than 2 tablets of this product in 24 hours
children under 12 years do not use

Drug Facts

Do Not Use: (Do not use:)

• with 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

Distributed By: (Distributed by:)

Cabinet Health P.B.C.

Other Information (Other information)

• store between 20–25°C (68–77°F)

Overdose Warning: (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.

Inactive Ingredients (Inactive ingredients)

FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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 more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness • pain gets worse or lasts for 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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 bronchitis • trouble urinating due to an enlarged prostate gland • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are If You Are (Ask a doctor or pharmacist before use if you are if you are)

• taking the blood thinning drug warfarin • taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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