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CHILDRENS CHEWABLE ACETAMINOPHEN  - acetaminophen tablet, chewable 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

Drug Facts

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.


WEIGHT AGE TABLETS
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 Type HUMAN OTC DRUG NDC Product Code (Source) 51645-711
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME  
SILICON DIOXIDE  
HYPROMELLOSES  
MAGNESIUM STEARATE  
MANNITOL  
POVIDONE  
STARCH, CORN  
SODIUM CHLORIDE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
SORBITOL  
STEARIC ACID  
SUCRALOSE  
Product Characteristics
Color pink Score no score
Shape ROUND (ROUND BICONVEX TABLET) Size 10mm
Flavor Imprint Code 1G
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 51645-711-30 30 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 12/03/2023

Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
Name Address ID/FEI Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270 manufacture
Revised: 12/2010Gemini Pharmaceuticals, Inc. dba Plus Pharma