ACETAMINOPHEN- acetaminophen tablet 
Spirit Pharmaceuticals LLC

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REGULAR STRENGTH PAIN RELIEVER

Drug facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

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 you take

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

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

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
  •  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

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

SPRIIT 360

REGULAR STRENGTH 

PAIN RELIEVER

ACETAMINOPHEN 325 mg

PAIN RELIEVER / FEVER REDUCER

100 TABLETS

image description

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4125
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)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code S31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4125-0100 in 1 BOTTLE; Type 0: Not a Combination Product04/06/2021
2NDC:68210-4125-11 in 1 CARTON04/06/2021
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/06/2021
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0c031bc3-42c4-dd6b-e063-6294a90ae2c8
Set id: 4388e547-7d74-4b1d-83b2-674a49ee38a1
Version: 3
Effective Time: 20231208
 
Spirit Pharmaceuticals LLC