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Acetaminophen Extra Strength by YILING PHARMACEUTICAL,INC.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500.4mg in 556mg
Labeler: YILING PHARMACEUTICAL,INC.
NDC Code: 69117-0002

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.

Active ingredient (in each caplet)

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Purpose

Pain reliever/fever reducer

Uses

Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • toothache
  • minor pain of arthritis
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver Warnings

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000mg) in 24 hours. 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

Allergy alert: Acetaminophen may cause severe skin reaction. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

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.

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

Ask a doctor before use if you have liver disease

Stop use and ask a doctor if

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Ask a doctor or pharmacist before use if you are

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

If pregnant or breast-feeding

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

Keep out of reach of children.

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 children12 years and over

  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children under12 years

do not use

Other information

Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

Inactive ingredients

corn starch, povidone K-30, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Questions or comments? 1-877-736-5697

You may also report serious side effects to this phone number.

Dosage & Administration

See Indications and Usage

Keep out of reach of children.

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.

Acetaminophen 500mg 100t ablets

Acetaminophen 500mg 1000tablets

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69117-0002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500.4 mg  in 556 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN38.92 mg  in 556 mg
SODIUM STARCH GLYCOLATE TYPE A CORN5.56 mg  in 556 mg
POVIDONE K308.34 mg  in 556 mg
STEARIC ACID2.78 mg  in 556 mg
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize7mm
FlavorImprint Code500
Contains    
Packaging
#Item CodePackage Description
1NDC:69117-0002-150000 mg in 1 BOTTLE
2NDC:69117-0002-2500000 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/15/201611/30/2018
Labeler - YILING PHARMACEUTICAL,INC. (079417422)
Registrant - Yiling Pharmaceutical Ltd (544322244)
Establishment
NameAddressID/FEIOperations
Yiling Pharmaceutical Ltd544322244manufacture(69117-0002)

 
YILING PHARMACEUTICAL,INC.

← See all Acetaminophen Extra Strength brands

Medically reviewed on Dec 26, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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