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 Bi-Mart, ELYSIUM PHARMACEUTICALS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain reliever
Diphenhydramine HCl 25 mg	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

• 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 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.

Overdose warning

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

Other information

• store between 20-25°C (68-77°F)
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

brilliant blue lake, colloidal silicon dioxide, indigo carmine lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, PVP-K30, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Questions?

call toll free 1-844-912-4012

PRINCIPAL DISPLAY PANEL-100 Count

NDC: 37835-537-01

Compare to the active ingredients in Extra Strength Tylenol ®PM*

EXTRA STRENGTH PAIN RELIEVER PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever / Nighttime Sleep Aid

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ®PM.

Distributed by:

BI-MART

Eugene, OR 97402

PRINCIPAL DISPLAY PANEL-250 Count

NDC: 37835-537-25

Compare to the active ingredients in Extra Strength Tylenol ®PM*

EXTRA STRENGTH PAIN RELIEVER PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever / Nighttime Sleep Aid

250 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ®PM.

Distributed by:

BI-MART

Eugene, OR 97402

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
acetaminophen and diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-537
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	APM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-537-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2025
2	NDC: 37835-537-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/01/2025

Labeler - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		915664486	manufacture(37835-537)