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← See all Acetaminophen Regular Strength brands

Acetaminophen Regular Strength

Medically reviewed on December 26, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 324.9mg in 361mg
Labeler: YILING PHARMACEUTICAL,INC.
NDC Code: 69117-0001

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 tablet)

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

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

Warnings

Liver warning:

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the user

Ask a doctor before use if the user

  • has liver disease
  • is a child with pain of arthritis

Ask a doctor or pharmacist before use

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

Stop use and ask a doctor if

  • pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children)
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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)

  • do not take more than directed (see Liver warning)

adults and children 12 years and over

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children 6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor

children under 6 years

ask a doctor

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.

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.

See Indications and usage

Acetaminophen 325mg/1000tablets package label

20150519Acetaminophen 325mg 1000tablets

Acetaminophen 325mg/100tablets Package label

Acetaminophen 325mg 1000tablets

ACETAMINOPHEN  REGULAR STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69117-0001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN324.9 mg  in 361 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A CORN3.61 mg  in 361 mg
POVIDONE K305.415 mg  in 361 mg
STEARIC ACID1.805 mg  in 361 mg
STARCH, CORN25.27 mg  in 361 mg
Product Characteristics
Colorwhite (white tablets) Scoreno score
ShapeROUND (bserving for four years stability test, we draw a conclusion that the all test items) Size10mm
FlavorImprint Code325
Contains    
Packaging
#Item CodePackage Description
1NDC:69117-0001-132500 mg in 1 BOTTLE
2NDC:69117-0001-2325000 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(69117-0001)

 
YILING PHARMACEUTICAL,INC.

← See all Acetaminophen Regular Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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