ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet

Acetaminophen and Diphenhydramine hydrochloride by

Drug Labeling and Warnings

Acetaminophen and Diphenhydramine hydrochloride by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY, Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each gelcap)

Acetaminophen USP 500 mg
Diphenhydramine hydrochloride USP 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

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:

• with other drugs containing acetaminophen
• more than 4,000 mg of acetaminophen in 24 hours
• 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
• if you are allergic to acetaminophen or any of the inactive ingredients in this product
• in children under 12 years of age

Ask a doctor before use if you have

• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the 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 beverages
• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
• new symptoms occur
• redness or swelling is present
• fever gets worse or lasts more than 3 days

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.

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 at bedtime
  • do not take more than 2 gelcaps of this product in 24 hours.
• children under 12 years: do not use

Other information

• avoid high humidity
• store at 20º to 25°C (68º to 77°F)
• use by expiration date on package

Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

Questions or comments?

Call 1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle)

NDC: 30142-193-14
Kroger®
               health

NON-HABIT
FORMING

EXTRA STRENGTH

Acetaminophen
PM
Acetaminophen USP, 500 mg

Diphenhydramine
Hydrochloride USP, 25 mg

PAIN RELIEVER,
NIGHTTIME SLEEP-AID
RAPID RELEASE

50
GELCAPS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (50 Caplets Bottle Carton)

NDC: 30142-193-14

Kroger®
               health

COMPARE TO THE ACTIVE INGREDIENTS
OF EXTRA STRENGTH TYLENOL® PM*

NON-HABIT
FORMING

EXTRA STRENGTH

Acetaminophen PM
Acetaminophen USP, 500 mg
Diphenhydramine Hydrochloride USP, 25 mg

DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN

PAIN RELIEVER,
NIGHTTIME SLEEP-AID
RAPID RELEASE

50 GELCAPS                ACTUAL SIZE

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen and diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-193
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
AMMONIA (UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
POVIDONE K90 (UNII: RDH86HJV5Z)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (Dark blue and Light blue with white band)	Score	no score
Shape	CAPSULE (Biconvex)	Size	20mm
Flavor		Imprint Code	T;6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-193-14	1 in 1 CARTON	03/06/2021
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	03/06/2021

Labeler - KROGER COMPANY (006999528)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(30142-193) , MANUFACTURE(30142-193)