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CrossingWell Consumer Health
PO Box 440
Cornwall, NY 12518
Pediacare Childrens Grape Suspension
FDA Label NDC 52412-901
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Randob Labs,ltd. Dba Crossingwell Consumer Health for the product Pediacare Childrens Grape (NDC 52412-901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), purpose, uses, liver warning, sore throat warning, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Otc - When Using
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.
Otc - Keep Out Of Reach Of Children
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
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
Principal Display Panel (118 mL Bottle Carton)
* Please review the disclaimer below.
