Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet
- NDC Code(s): 37835-537-01, 37835-537-25
- Packager: Bi-Mart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 2, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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.
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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
- Inactive ingredients
- Questions?
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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

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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

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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen and diphenhydramine hydrochloride tabletProduct 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)
