Acetaminophen Tablets, 325 mg

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen tablet 
Cardinal Health

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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Acetaminophen Tablets, 325 mg

Active ingredient

Acetaminophen, 325 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning

This product contains acetaminophen. 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
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

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 liver disease.

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

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children under 12 years)
  • 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.

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 (see overdose 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

  • store at 20°-25°C (68°-77°F)
  • save carton for full directions and warnings

Inactive ingredients

corn starch, crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid

Questions or comments?

1-888-341-9214

Package/Label Principal Display Panel

NDC: 70000-0104-2

Pain Reliever

Acetaminophen, 325 mg

Pain Reliever/Fever Reducer

Regular Strength, Contains No Aspirin

See New Warnings

50 Tablets

Acetaminophen Carton

Package/Label Principal Display Panel

NDC: 70000-0104-2

Pain Reliever

Acetaminophen, 325 mg

Pain Reliever/Fever Reducer

Regular Strength, Contains No Aspirin

See New Warnings

50 Tablets

C:\Users\mcraddock\Documents\SPL\Acetaminophen 325 mg\Acetaminophen 325mg 50ct_Carton Old Style Guide.jpg
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-0104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code APAP;325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70000-0104-11 in 1 CARTON08/15/201601/31/2020
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 70000-0104-21 in 1 CARTON08/15/201601/31/2020
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 70000-0104-3500 in 1 BOTTLE; Type 0: Not a Combination Product08/15/201601/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/15/201601/31/2020
Labeler - Cardinal Health (097537435)

Revised: 2/2020
 
Cardinal Health