Chiidren's Pain Relief Oral Suspension, Dye free
Childrens Pain Relief Oral Suspension Dye free by
Drug Labeling and Warnings
Childrens Pain Relief Oral Suspension Dye free by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC, Aptapharma Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
CHILDRENS PAIN RELIEF ORAL SUSPENSION DYE FREE- acetaminophen suspension
WinCo Foods, LLC
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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Chiidren's Pain Relief Oral Suspension, Dye free
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
Allergy alert
Acetaminophen may cause severe skin reactions.
Symptoms may include: ■ skin reddening ■ blisters
■ rash. If 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 nonprescription). 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.
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.
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
■ this product does not contain directions or complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find right dose on chart below. If possible, use
weight to dose; otherwise, use age.
■ 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
| Weight (lb) | Age (yr) | Dose (mL or tsp)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL (1 tsp) |
| 36-47 | 4-5 years | 7.5 mL (1 1/2 tsp) |
| 48-59 | 6-8 years | 10 mL (2 tsp) |
| 60-71 | 9-10 years | 12.5 mL (2 1/2 tsp) |
| 72-95 | 11 years | 15 mL (3 tsp) |
* or use as directed by a doctor
Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device.
Other information
■ each 5 mL (1 tsp) contains: sodium 3 mg
■ store between 20-25ºC (68-77ºF)
■do not refrigerate
■ Keep carton for full directions for use.
Inactive ingredients anhydrous citric acid,
butylparaben, flavor, glycerin, high fructose corn
syrup, microcrystalline cellulose and
carboxymethylcellulose sodium, propylene glycol,
purified water, sodium benzoate, sorbitol solution,
sucralose, xanthan gum
Package Labeling
WinCo®
FOODS
ORAL SUSPENSION
Pain Relief
Children's
**Compare to the active ingredient in
Children's TYLENOL® Oral Suspension
ACETAMINOPHEN
160 mg per 5 mL/
PAIN RELIEVER - FEVER REDUCER
Alcohol Free
Aspirin & Ibuprofen Free
For Ages 2 - 11 Years
Dye
Free
Cherry
Flavor
4 FL OZ (118 mL) 160 mg per 5 mL
DISTRIBUTED BY: WINCO FOODS,LLC, BOISE, ID 83704
**This product is not manufactured or distributed by
McNEIL CONSUMER HEALTHCARE, distributor of
Children's TYLENOL® Oral Suspension.
DO NOT USE IF PRINTED SEAL
UNDER CAP IS TORN OR MISSING
Carton Label
Bottle Label
res
| CHILDRENS PAIN RELIEF ORAL SUSPENSION DYE FREE
acetaminophen suspension |
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| Labeler - WinCo Foods, LLC (056098817) |
| Registrant - Aptapharma Inc. (790523323) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aptapharma Inc. | 790523323 | manufacture(67091-376) | |
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