ACETAMINOPHEN (RED)- acetaminophen capsule, liquid filled 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

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 CAPSULES 325 mg, liquid filled

Drug Facts

Active ingredient (in each capsule)

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 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if

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

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

Children 6-11 years
  • take 1 softgel every 4 to 6 hours while symptoms last
  • do not take more than 5 softgels 24 hours
  • do not use for more than 5 days unless directed by a doctorr

children under 6 years
  • ask a doctor

Other information

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink.

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

ACETAMINOPHEN CAPSULES, 325 mg

Quantity : 5000 Capsules
NDC. No : 53345-010-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Shipping Label

ACETAMINOPHEN (RED) 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorred (clear) Scoreno score
ShapeCAPSULE (oblong) Size20mm
FlavorImprint Code PC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53345-010-011 in 1 BOX04/15/2013
15000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/15/2013
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-010) , ANALYSIS(53345-010)

Revised: 11/2019
Document Id: c29edf43-69e6-4893-affc-737d2ff28929
Set id: 06eabf4b-f8c0-439a-acf1-aa6e3075c717
Version: 2
Effective Time: 20191122
 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.