PEDIACARE CHILDRENS GRAPE- acetaminophen suspension

Pediacare Childrens Grape by

Drug Labeling and Warnings

Pediacare Childrens Grape by is a Otc medication manufactured, distributed, or labeled by RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to:
  • sore throat
  • the common cold
  • flu
  • headache
  • 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 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use. Shake well before using
• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• repeat dose every 4 hours while symptoms last
• measure only with dosage cup provided
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor.

Weight (lb.)	Age (yrs.)	Dose (ml)*
* always check with your doctor before administering medicine to your infant/child
Under 24	Under 2	Ask a doctor
24 – 35	2 - 3	5mL
36 – 47	4 - 5	7.5 mL
48 – 59	6 - 8	10mL
60 – 71	9 - 10	12.5mL
72- 95	11	15mL

Other information

• Store between 15° - 30° C (59° - 86° F)
• Protect from Freezing
• Protect from Light

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Fast Acting
Pedia
Care®
100% dedicated
to kids™

2-11 Years

ACETAMINOPHEN

Pain Reliever/
Fever Reducer

Acetaminophen (160 mg per 5mL)
Oral Suspension

Alcohol Free
Asprin Free
Ibuprofen Free
No Parabens

Grape Flavor

4 FL OZ (118 mL)
160 mg per 5 mL

INGREDIENTS AND APPEARANCE

PEDIACARE CHILDRENS GRAPE 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-901
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-901-04	1 in 1 CARTON	01/03/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/03/2023

Labeler - RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH (061995007)