DrugCite

ACETAMINOPHEN PM  - acetaminophen and diphenhydramine hydrochloride tablet 
Advance Pharmaceutical Inc.

ACETAMINOPHEN-PM

Active Ingredient

(in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain Reliever / Night time sleep aid

Uses

temporarily 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

do not use

  • with any other drug containing acetaminophen (prescription or non prescription).If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine, even one used on skin
  • in children under 12 years of age

Ask a doctor before use if the you have

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedative 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.
  • Any new symptoms appear
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of 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 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
  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years : do not use this adult product in children under 12 years of age; this will provide more than the recommended dose(overdose) and may cause liver damage

Other Information

  • store at 15-30 °C (59-86 °F)

Inactive Ingredients

crosscarmellose sodium, FD&C blue # 1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, silicon dioxide, starch, stearic acid, titanium dioxide

Questions or Comments

Call 631-981-4600 8.30 am- 4.30 pm ET, Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

079fcfcb-figure-01

079fcfcb-figure-02

NDC: 17714-133-50 – 50 COUNT CAPLETS


ACETAMINOPHEN PM 
acetaminophen pm  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 17714-133
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 1  
HYPROMELLOSES  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL 400  
POVIDONE  
SILICON DIOXIDE  
STARCH, CORN  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code AP;133
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 17714-133-50 50 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/09/2022

Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
Name Address ID/FEI Operations
Advance Pharmaceutical Inc. 078301063 MANUFACTURE
Revised: 04/2013Advance Pharmaceutical Inc.