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Name:Acetaminophen Pm
Manufacturer:Tds Pharm Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ACETAMINOPHEN PM  - acetaminophen and diphenhydramine hydrochloride tablet 
TDS Pharm Co., Ltd.

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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Drug Facts

Active Ingredients (in each caplet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain reliever

Sleep aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessnes

Warnings

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Liver warning:

This product contains acetaminophen.  Severe liver damage may occur if you take

  • more than 4,000ms 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 nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a a doctor or pharmacist.
  • with any other 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
  • 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 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
  • 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.

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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.  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 under 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

Other information

  • do not use if safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • see end panel for lot number and expiration date

Inactive ingredients

corn starch, cydroxypropyl cellulose, hypromellose 2910, blue no.1, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, titanium dioxide


non-aspirin PMimage of carton label


ACETAMINOPHEN PM 
acetaminophen, diphenhydramine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42912-0154
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
STARCH, CORN  
FD&C BLUE NO. 1  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL 6000  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TITANIUM DIOXIDE  
Product Characteristics
Color blue (blue) Score no score
Shape ROUND Size 17mm
Flavor Imprint Code PM
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42912-0154-2 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE
1 24 TABLET ( CAPSULE) in 1 BOTTLE This package is contained within the BOX (42912-0154-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/28/2011

Labeler - TDS Pharm Co., Ltd. (689951176)
Registrant - TDS Pharm Co., Ltd. (689951176)
Establishment
Name Address ID/FEI Operations
TDS Pharm Co., Ltd. 689951176 manufacture

Revised: 01/2011 TDS Pharm Co., Ltd.



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


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