Extra Strength

Extra Strength
SPL v7
SPL
SPL Set ID 8c9f68e3-fedc-6457-e053-2995a90a045a
Route
ORAL
Published
Effective Date 2019-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Acetaminophen (500 mg)
Inactive Ingredients
Fd&c Blue No. 2 Polyethylene Glycol, Unspecified Povidone Stearic Acid Croscarmellose Carnauba Wax Silicon Dioxide Fd&c Blue No. 1 Hypromellose, Unspecified Microcrystalline Cellulose Starch, Corn Titanium Dioxide Polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: G;651 Shape: oval Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-01

Description

(in each caplet) Acetaminophen, USP 500mg Diphenhydramine HCl. 25mg

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever Nighttime sleep-aid

Description

(in each caplet) Acetaminophen, USP 500mg Diphenhydramine HCl. 25mg

Uses

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

Purposes

Pain reliever

Nighttime sleep-aid

Directions

■ do not take more than directed (see overdose warning)

adults andchildren 12 years and over

■ take 2 caplets at bedtime do not use

■ do not take more than 2 caplets of this product in 24 hours

children under 12 years

■ do not use

Dso 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

Allergy Alert

acetaminophen may cause severs skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away

Liver Warning

This product containsacetaminophen. 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

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

■ see end panel for expiration date and lot number

Active Ingridients

(in each caplet)

Acetaminophen, USP 500mg

Diphenhydramine HCl. 25mg

Inactive Ingridients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone,pregelatinized starch, stearic acid, titanium dioxide

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 morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness

■ pain gets worse or lasts more t han 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.

Ask A Doctor Before Use If You Have

■ liver disease

■ a breathing problem such as emphysema or chronic brochitis

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

Ask A Doctor Or Pharmacist Before Use If You Have

■ 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.

Purposes

Pain reliever

Nighttime sleep-aid

Directions

■ do not take more than directed (see overdose warning)

adults andchildren 12 years and over

■ take 2 caplets at bedtime do not use

■ do not take more than 2 caplets of this product in 24 hours

children under 12 years

■ do not use

Dso Not Use (DSo 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

Allergy Alert (Allergy alert)

acetaminophen may cause severs skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away

Liver Warning (Liver warning)

This product containsacetaminophen. 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

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)

■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

■ see end panel for expiration date and lot number

Active Ingridients (Active ingridients)

(in each caplet)

Acetaminophen, USP 500mg

Diphenhydramine HCl. 25mg

Inactive Ingridients (Inactive ingridients)

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone,pregelatinized starch, stearic acid, titanium dioxide

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 morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness

■ pain gets worse or lasts more t han 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.

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 brochitis

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

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

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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