Your browser does not support JavaScript! CHILDRENS CHEWABLE ACETAMINOPHEN (ACETAMINOPHEN) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA ]
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CHILDRENS CHEWABLE ACETAMINOPHEN (acetaminophen) tablet, chewable
[Gemini Pharmaceuticals, Inc. dba Plus Pharma ]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredients (in each chewable tablet)

Acetaminophen 80 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily relieves minor aches and pain due to:

■ The common cold  ■ Flu  ■ Headache  ■ Sore throat

■ Toothache

Temporarily reduces fever.

Warnings

Liver Warning: This Product contains acetaminophen. Severe liver damage may occur if your child takes ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen.

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 other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
■ If your child is allergic to acetaminophen or any of the inactive ingredients in this products.


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 dose.

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.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

This products does not contain directions or complete warning for adult use.
■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
■ Chew before swallowing
■ If needed, repeat dose every 4 hours while symptoms lasts
■ Do not give more than 5 times in 24 hours
■ Do not give for more than 5 days unless directed by a doctor.


WEIGHTAGETABLETS
Under 24 lbs
Under 2 years
Ask a doctor
24-35 lbs
2-3 years
2 tablets
36-47 lbs
4-5 years
3 tablets
48-59 lbs
6-8 years
4 tablets
60-71 lbs
9-10 years
5 tablets
72-95 lbs
11 years
6 tablets

Other Information

  • Phenylketonurics: Contain phenylalanine 14 mg per tablet
  • Store at room temperature in a dry place

Inactive Ingredients


Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

Questions?

If you have any questions or comments, or to report an adverse drug event, please contact (800) 795-9775.

Principal Display Panel

See New Warning Information

PlusPHARMATM

Children's Chewable

ACETAMINOPHEN

PAIN RELIEVER/FEVER REDUCER

                CONTAINS NO ASPIRIN

*Compare the active ingredients to  Children Chewable Tylenol®

30 Chewable Tablet    ■ 80 mg EachPharma Plus Children's chewable Acetaminophen 80mg

Rev. 06/10

Do not use if imprinted seal under cap is broken or missing.

CHILDRENS CHEWABLE ACETAMINOPHEN 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51645-711
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
SILICON DIOXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONE 
STARCH, CORN 
SODIUM CHLORIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
SORBITOL 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorpinkScoreno score
ShapeROUND (ROUND BICONVEX TABLET) Size10mm
FlavorImprint Code 1G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51645-711-3030 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/03/2010
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270manufacture

Revised: 12/2010
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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