Little Remedies Infant Berry Fever Pain Reliever
Drug Labeling and Warnings
Drug Details [pdf]
LITTLE REMEDIES INFANT BERRY FEVER/PAIN RELIEVER- 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 Remedies Infant Berry Fever Pain Reliever
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.
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.
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.
When using this product
DO NOT EXCEED RECOMMENDED DOSAGE; taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.
Overdose
Warning: 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 (1-800-222-1222) immediately. Prompt medical attention is critical 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.
- Find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.)
- Only use the enclosed AccuSafe TM syringe.
- Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
- Remove cap, attach syringe to flow restrictor and invert bottle.
- Pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward the inner cheek).
- If needed, repeat dose every 4 hours while symptoms last.
- Do not give more than 5 times in any 24-hour period (see overdose warning).
- Replace cap tightly to maintain child resistance.
| Weight (lbs) | Age (yrs) | Dose |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 5.0 mL |
Other information
- Store at 20-25
ºC (68-77
ºF)
- AccuSafe
TM dosing device enclosed.
- Tamper Evident: Do not use if printed shrinkband on bottle is broken or missing. Check expiration date on bottle or box before using.
Inactive ingredients
Citric Acid, Glycerin, Natural Flavors, Potassium Sorbate, Povidone, Propylene Glycol, Purified Water, Sodium Citrate, Sucralose, Sucrose, Xanthan Gum
| LITTLE REMEDIES INFANT BERRY FEVER/PAIN RELIEVER
acetaminophen liquid |
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| Labeler - Denison Pharmaceuticals, Inc. (001207208) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Denison Pharmaceuticals, Inc. | 001207208 | manufacture(0295-1626) | |