CHEWABLE ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable 
Richmond Pharmaceuticals, 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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APAP Children Chewable Tablets, 80 mg

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

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

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 days
  • 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.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Weight (lb)Age (yr)Dose (tablets)*
Under 24Under 2Ask a doctor
24-352-32
36-474-53
48-596-84
60-719-104-5
72-9511-124-6

*or as directed by a doctor

Other information

Inactive ingredients

aspartame, compressible sugar, D&C red #27(Al lake), dextorse, FD&C yellow #6(Al lake), fruit flavor, magnesium stearate, microcrystaline cellulose, prosweet, stearice acid

Questions or comments?

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

Principal display panel

NDC- 54738-092-30 -  APAP 80MG CHEWABLE- 30 TABS

IMG_4671

CHEWABLE ACETAMINOPHEN  CHILDRENS
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-092
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
INVERT SUGAR (UNII: ED959S6ACY)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorpink (light) Score2 pieces
ShapeROUNDSize10mm
FlavorFRUITImprint Code AP;051
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54738-092-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2015
Labeler - Richmond Pharmaceuticals, Inc. (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(54738-092)

Revised: 10/2017
Document Id: 5cc5fab2-77b5-05c5-e053-2991aa0a272d
Set id: a5dd9031-a960-4a98-ab71-05b079183f1a
Version: 2
Effective Time: 20171030
 
Richmond Pharmaceuticals, Inc.