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Pain Reliever Infants

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Select Brand Dist.
NDC Code: 15127-322

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.

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily reduces fever

  • temporarily 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

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

  • skin reddening
  • blisters
  • rash

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 non prescription). 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 dose (see overdose warning)

Stop use and ask a doctor if
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

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 case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL= milliliter
  • only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child
  • remove cap, insert syringe into hole at top of bottle until it snaps into place and turn upside down
  • pull back syringe until filled to be prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)
  • If needed, repeat dose every 4 hours while syptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • replace cap tightly to maintain child resistance
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb)Age (yr)  Dose (mL)*
 under 24 under 2 ask a doctor
 24-35 2-3 5 mL

*or as directed by a doctor

Other information
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate.
  • see bottom panel for lot number and expiration date

Inactive ingredients

butylparaben, carboxymethylcellulose sodium, citric acid, flavors, glycerin, high fructose corn syrup, microcrystalline celllulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call 1-877-723-3929 Monday-Friday 9AM-5PM EST

Principal Display Panel

Infants' Pain Relief

Acetaminophen

160 mg per 5 mL

Oral suspension

Pain Reliever / Fever Reducer

**Compare to the active ingredient in Infants'  Tylenol® Oral Suspension 

Alcohol free

Aspirin free

Ibuprofen free

For Ages 2 to 3 Years

Use Only Enclosed Syringe

Cherry Flavor Dye-Free

FL OZ (mL)

CHERRY FLAVOR

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Infants' Tylenol® Oral Suspension.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED SAFETY SEAL AROUND THE BOTTLE IS BROKEN OR MISSING.

Distributed by:

SELECT BRAND® DISTRIBUTORS

Pine Bluff, AR 71603 USA

AC (870) 535-3635

Package Label

 

Select Brand Infants' Pain Reliever Cherry Liquid

PAIN RELIEVER  INFANTS
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-322
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
ANHYDROUS CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
CELLULOSE, MICROCRYSTALLINE 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:15127-322-011 BOTTLE in 1 BOX
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/30/2015
Labeler - Select Brand Dist. (012578514)

Revised: 12/2015
 
Select Brand Dist.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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