Acetaminophen Diphenhydramine HCl ACETAMINOPHEN DIPHENHYDRAMINE HCL GRANULES USA, INC. FDA Approved Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingridients (in each caplet) Acetaminophen USP 500mg Diphenhydramine HCl. 25mg
Inactive Ingredients
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
Strengths
500 mg 25 mg
Treats Conditions
Uses Temporary Relief Of Occasional Headaches And Minor Aches And Pains With Accompanying Sleeplessness
Pill Appearance
Shape: oval Color: blue Imprint: G;651

Identifiers & Packaging

Container Type UNKNOWN
UNII
362O9ITL9D TC2D6JAD40
Packaging

Principal Display Panel 20ct; Principal Display Panel 50ct; Principal Display Panel 150ct

Package Descriptions
  • Principal Display Panel 20ct
  • Principal Display Panel 50ct
  • Principal Display Panel 150ct

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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 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
Purpose

Purposes Pain reliever Nighttime sleep-aid

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

When Using

When using this product ■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

Keep out of the reach of chlidren.

Storage & Handling

Other information ■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. ■ see end panel for expiration date and lot number

Questions

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