ACETAMINOPHEN DIPHENHYDRAMINE HCL tablet

Acetaminophen Diphenhydramine HCL by

Drug Labeling and Warnings

Acetaminophen Diphenhydramine HCL by is a Otc medication manufactured, distributed, or labeled by WALGREENS CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each gelcap)

Acetaminophen USP, 500mg

Diphenhydramine HCL USP,25mg

Purposes

Pain reliever

Nighttime sleep aid

Uses

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

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

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

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 serious underlying medical illness.

■ pain gets worse or lasts 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

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.

Directions

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

adults and children 12 years and over

■ take 2 gelcaps at bedtime

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

children under 12 years

■ do not use

Other information

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

■ see bottom of the label for expiration date and lot number.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow#10, FD&C blue#1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

Questions or comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Principal Display Panel

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN DIPHENHYDRAMINE HCL 
acetaminophen diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9664
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	gray (Encapsulated gray color tablets with dark blue opaque and light blue opaque hard gelatin shells)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	G3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9664-60	125 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2022
2	NDC: 0363-9664-37	375 in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	09/30/2022

Labeler - WALGREENS CO. (008965063)