ACETAMINOPHEN 325MG RS- acetaminophen 325mg tablet 
Allegiant Health

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Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer


Uses

temporary relief of minor aches and pains associated with:

Warnings

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

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

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

Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). 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 user has

liver disease.

Ask a doctor or pharmacist before use if

  • the user is taking the blood thinning drug warfarin
  • is a child with pain of arthritis

Stop use and ask a doctor if

  • Adult’s pain gets worse or lasts more than 10 days
  • Child’s pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

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 (1-800-222-1222) 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

Adults and children 12 years and over:

Children 6-11 years of age:

Children under 6 years: ask a doctor

Other information

Inactive ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

Pain Relief

Pain Relief

Pain Relief

Pain Relief


ACETAMINOPHEN 325MG  RS
acetaminophen 325mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-010
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)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (Round Circle) Size11mm
FlavorImprint Code AZ;010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-010-601 in 1 CARTON04/15/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69168-010-501 in 1 CARTON04/15/2016
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69168-010-301 in 1 CARTON12/15/2021
330 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/15/2016
Labeler - Allegiant Health (079501930)

Revised: 1/2019
Document Id: 92f2ab65-26c5-4e2e-9f13-1d7836c8d559
Set id: 61c6d281-e59b-4277-bbce-f71c12c2a56d
Version: 4
Effective Time: 20190107
 
Allegiant Health