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

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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Children's Chewable Acetaminophen

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 lbsUnder 2 yearsAsk a doctor
24-35 lbs2-3 years2 tablets
36-47 lbs4-5 years3 tablets
48-59 lbs6-8 years4 tablets
60-71 lbs9-10 years5 tablets
72-95 lbs11 years6 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
PlusPHARMA TM

Children's Chewable

ACETAMINOPHEN

PAIN RELIEVER/FEVER REDUCER

CONTAINS NO ASPIRIN

*Compare the active ingredients to Children Chewable Tylenol ®

30 Chewable Tablet ■ 80 mg Each Pharma 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 DRUGItem Code (Source)NDC:51645-711
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
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; Type 0: Not a Combination Product12/03/201011/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/03/201011/30/2017
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma055942270manufacture(51645-711)

Revised: 11/2017
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma