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NDC 00363-9991-75 Acetaminophen Diphenhydramine HCl 500; 25 mg/1; mg/1 Details

Acetaminophen Diphenhydramine HCl 500; 25 mg/1; mg/1

Acetaminophen Diphenhydramine HCl is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREEN CO.. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 00363-9991-75
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00363-9991-75
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	00363-9991
Product ID	0363-9991_b1426006-7fe0-e197-e053-2a95a90a6889
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Acetaminophen Diphenhydramine HCl
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500; 25
Active Ingredient Units	mg/1; mg/1
Substance Name	ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	WALGREEN CO.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2022-12-31

Package

Package Images

NDC 00363-9991-75 (00363999175)

Pricing Information	N/A
NDC Package Code	0363-9991-75
Billing NDC	00363999175
Package	75 TABLET in 1 BOTTLE (0363-9991-75)
Marketing Start Date	2020-07-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9a01ab86-eed1-5f1d-e053-2a95a90aff56 Details

ACETAMINOPHEN GELCAPS Active ingredient

(in each Gelcap)

Acetaminophen, USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

■ temporarily reduces fever

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

■ 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.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of accidental 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.

Directions

■ do not take more than directed

adults and children 12 years and over

■ take 2 gelcaps every 6 hours while symptoms last

■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor

■ do not take more than 10 days unless directed by a doctor

children under 12 years

■ ask a doctor

Other information

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

■ avoid high humidity

■ see end panel for lot number and expiration date

Inactive ingredients

ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

ACETAMINOPHEN PM GELCAPS Active ingredient

(in each gelcap)

Acetaminophen, USP 500 mg

Diphenhydramine HCl, USP 25 mg

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 the reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 end panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, 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 9:00 AM to 4:30 PM EST.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN DIPHENHYDRAMINE HCL

acetaminophen diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-9991
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
AMMONIA (UNII: 5138Q19F1X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIACETIN (UNII: XHX3C3X673)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	gray (Encapsulated gray color tablets with one red opaque and one blue-gray opaque hard gelatin shells) , 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	G1;G3
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-9991-75	75 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	07/26/2020

Labeler - WALGREEN CO. (008965063)

Revised: 10/2020

Document Id: b1426006-7fe0-e197-e053-2a95a90a6889

Set id: 9a01ab86-eed1-5f1d-e053-2a95a90aff56

Version: 2

Effective Time: 20201009

Search by Drug Name or NDC

NDC 00363-9991-75 Acetaminophen Diphenhydramine HCl 500; 25 mg/1; mg/1 Details

Acetaminophen Diphenhydramine HCl 500; 25 mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-9991-75 (00363999175)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9a01ab86-eed1-5f1d-e053-2a95a90aff56 Details

ACETAMINOPHEN GELCAPS Active ingredient

Purpose

Uses

Liver warning

Allergy alert

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of the reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

ACETAMINOPHEN PM GELCAPS Active ingredient

Purposes

Uses

Liver warning

Allergy alert

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of the reach of children.

Overdose warning:

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE