PEDIACARE CHILDRENS ACETAMINOPHEN GRAPE- acetaminophen suspension 
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH

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.

----------

Pediacare® Children's Acetaminophen Grape

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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 right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Weight (lb)Age (yr)Dose (mL)*
*
or as directed by doctor
under 24under 2 yrask a doctor
24-352-3 yr5 mL

Other information

Inactive ingredients

acesulfame potassium, citric acid, corn syrup, FD&C blue #1, FD&C red #33 flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Distributed by
CrossingWell
Consumer Health
PO Box 440
Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Fast Acting
Pedia
Care®
100% dedicated
to kids™

Infants

ACETAMINOPHEN

Pain Reliever/
Fever Reducer

Acetaminophen (160 mg per 5mL)
Oral Suspension

Alcohol Free, Asprin Free
Ibuprofen Free, No Parabens

Grape Flavor
(Use Only Enclosed Syringe)

1 FL OZ (30mL)
160 mg per 5 mL

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
PEDIACARE CHILDRENS ACETAMINOPHEN GRAPE 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-906
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-906-011 in 1 CARTON01/03/2023
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/03/2023
Labeler - RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH (061995007)

Revised: 12/2022
Document Id: 007e4eee-3603-46fc-b7fd-978f06805d06
Set id: 596372c7-eca3-4527-8e22-ab0751e2526b
Version: 2
Effective Time: 20221222
 
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH