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Name:Acetaminophen Pm
Manufacturer:Western Family Foods Inc
Category:Over-the-counter (OTC) Marketed Drugs


Western Family Acetaminophen PM Drug Facts

ACETAMINOPHEN PM - acetaminophen and diphenhydramine hydrochloride tablet, film coated 
Western Family Foods Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Western Family Acetaminophen PM Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 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

  • 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

  • in children under 12 years of age
  • 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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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 lasts 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.

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 (see Liver 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients

carnauba wax, crospovidone, FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Principal Display Panel

See New Warnings Information

Extra Strength

Aspirin Free

Acetaminophen PM

Pain Reliever plus Nighttime Sleep Aid

Acetaminophen/Diphenhydramine HCl

Gluten Free

Compare to Tylenol® PM active ingredients

Acetaminophen PM Carton

Acetaminophen PM Carton


ACETAMINOPHEN PM 
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-437
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
CARNAUBA WAX  
CROSPOVIDONE  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POLYSORBATE 80  
POVIDONE  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE (Light blue) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code L437;PM
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55312-437-71 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 50 TABLET, FILM COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55312-437-71)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 11/18/1992

Labeler - Western Family Foods Inc (192166072)

Revised: 05/2009 Western Family Foods Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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