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Name:Non Aspirinchildrens
Manufacturer:Rite Aid Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Rite Aid Corporation Non Aspirin Drug Facts

NON ASPIRIN CHILDRENS - acetaminophen suspension 
Rite Aid Corporation

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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Rite Aid Corporation Non Aspirin Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

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 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

  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • this product does not contain directions or complete warnings for adult use
Weight(lb) Age(yr) Dose (tsp or mL)
under 24 under 2 years ask a doctor
24-35 2–3 years 1 tsp or 5 mL
36–47 4–5 years 1 1/2 tsp or 7.5 mL
48–59 6–8 years 2 tsp or 10 mL
60-71 9–10 years 2 1/2 tsp or 12.5 mL
72-95 11 years 3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Children’s Tylenol® Oral Suspension

Children’s

Acetaminophen

Non Aspirin

See New Warnings Information

Grape Flavor

Fever Reducer

Pain Reliever

Oral Suspension Liquid

80 mg per 1/2 teaspoon (160 mg per 5 mL)

Non Aspirin Carton Image #1

Non Aspirin Carton Image #1

Non Aspirin Carton Image #2

Non Aspirin Carton Image #2


NON ASPIRIN  CHILDRENS
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0130
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID  
BUTYLPARABEN  
CARBOXYMETHYLCELLULOSE SODIUM  
CARRAGEENAN  
D&C RED NO. 33  
FD&C BLUE NO. 1  
GLYCERIN  
HIGH FRUCTOSE CORN SYRUP  
CELLULOSE, MICROCRYSTALLINE  
PROPYLENE GLYCOL  
WATER  
SODIUM BENZOATE  
SORBITOL  
Product Characteristics
Color PURPLE (viscous) Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-0130-4 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (11822-0130-4)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 09/23/1997

Labeler - Rite Aid Corporation (014578892)

Revised: 09/2009 Rite Aid Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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