LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER GRAPE- acetaminophen liquid
Denison Pharmaceuticals, Inc.
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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Little Fevers Childrens Fever Pain Reliever Grape
Active Ingredient
| Active Ingredient | Purpose |
| Acetaminophen 160mg | Pain Reliever/Fever Reducer |
Uses
Temporarily:
- Reduces fever
- Relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use:
- With any other products 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.
OverdoseWarning:
Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of symptoms.
Directions
This product does not contain directions or complete warnings for adult use.
- Do not give more than directed (see overdose warning).
- Shake well before using.
- Find the right dose on the chart below. (If possible, use weight to determine dosing; otherwise, use age.)
- Invert bottle and gently squeeze liquid into AccuSafe TM dosing cup to the appropriate amount for your child’s weight and/or age.
- Only use with enclosed AccuSafe TM dosing cup.
- If needed, repeat dose every 4 hours while symptoms last.
- Do not give more than 5 days in any 24-hour period (see overdose warning).
- Do not give more than 5 days unless directed by a doctor.
- Replace cap tightly to maintain child resistance.
| Weight (lb) | Age (yr) | Dose |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2 – Under 4 | 1 tsp or 5mL |
Other Information
- Store at 20-25ºC (68-77ºF)
- AccuSafe
TM Dosing cup enclosed.
-
Tamper Evident: DO NOT USE if printed skrink band on bottle is broken or missing.
- Check expiration date on bottle or box before using.
Inactive Ingredients:
Citric Acid, Glycerin, Natural Grape Flavor, Potassium Sorbate, Povidone, Polyethylene Glycol, Purified Water, Sodium Citrate, Sucralose,Sucrose, Xanthan Gum
| LITTLE REMEDIES INFANT FEVER/PAIN RELIEVER GRAPE
acetaminophen liquid |
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| Labeler - Denison Pharmaceuticals, Inc. (001207208) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Denison Pharmaceuticals, Inc. | 001207208 | manufacture(0295-1610) | |