ACETAMINOPHEN- acetaminophen tablet 
Cardinal Health, 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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Regular Strength Acetaminophen Tablets, 325 mg

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • toothache
  • the common cold
  • premenstrual and menstrual cramps
  • 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, 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: 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 the user has liver disease.

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

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in 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: 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 unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
  • takes 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 room temperature

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or Comments?

call (800) 795-9775

Do not use if carton is open, or if imprinted safety seal under cap is broken or missing

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

NDC 70000-0152-1

Leader™

Regular Strength

Acetaminophen

Tablets, 325 mg | Pain Reliever / Fever Reducer

For Relief of:

Headache, Fever, Aches and Pains

Aspirin Free

24 TABLETS

Leader Apap 325 mg 24-ct

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0152
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code GPIA325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0152-11 in 1 CARTON11/28/201601/31/2020
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70000-0152-3225 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201603/31/2020
3NDC:70000-0152-21 in 1 CARTON01/25/201705/31/2021
3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:70000-0152-4500 in 1 BOTTLE; Type 0: Not a Combination Product02/02/201703/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/28/201605/31/2021
Labeler - Cardinal Health, Inc. (097537435)

Revised: 8/2018
 
Cardinal Health, Inc.