Indications and uses
Temporarily: Reduces fever Relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
Little Remedies Infant Fever/Pain Reliever Natural Grape
- Manufacturer
- Denison Pharmaceuticals, Inc.
- Effective date
- 2019-04-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:25:36
Label at a glance#
ProductLittle Remedies Infant Fever/Pain Reliever Natural Grape Natural Grape
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
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 side panel. (If possible, use weight to determine dose; otherwise, use age.) Only use with enclosed AccuSafe ® syringe Remove cap, insert syringe to flow restrictor and invert bottle Pull back syringe until filled to the prescribed level...
Contacts and useful links#
Websitewww.littleremedies.com
www.LittleRemedies.com
www.LittleRemedies.comLabel contents#
Full prescribing information#
Active Ingredient
| Active Ingredient | Purpose |
| Acetaminophen 160mg | Pain Reliever/Fever Reducer |
Purpose
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.
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddining
- 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Ask a doctor before use
If your child has liver disease.
Ask a doctoror pharmacist before use
If your child is taking the blood thinning drug warfarin.
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.
When using this product,
- DO NOT EXCEED RECOMMENDED DOSAGE (see overdose warning).
Stop use and ask a doctor if:
- New symptoms occur.
- Fever gets worse or lasts more than 3 days.
- Pain gets worse or lasts more than 5 days.
- Redness or swelling is present. These could be signs of a serious condition.
Keep out of reach of children.
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 side panel. (If possible, use weight to determine dose; otherwise, use age.)
- Only use with enclosed AccuSafe ® syringe
- Remove cap, insert syringe to flow restrictor and invert bottle
- Pull back syringe until filled to the prescribed level and slowly dispense the liquid into your child's mouth (towards the inner cheek)
- If needed, repeat dose every 4 hours while symptoms last.
- Do not give more than 5 days in any 24-hour period
- Replace cap tightly to maintain child resistance. mL = mililiter
| Weight (lb) | Age (yr) | Dose |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2 – 3 | 5mL |
Other Information
- Each 5 mL contains: sodium 6 mg
- Store at 20-25ºC (68-77ºF)
- AccuSafe ® Oral dosing device enclosed
- Check expiration date on bottle or box before using
Inactive Ingredients:
Benzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum
Questions?
For further information you may contact us at:
1-800-754-8853 Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.
PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Little Remedies Infant Fever/Pain Reliever Natural Grape Natural Grape
- Acetaminophen
- GLYCERIN
- WATER
- SUCRALOSE
- XANTHAN GUM
- SODIUM BENZOATE
- MICROCRYSTALLINE CELLULOSE
- CARBOXYMETHYLCELLULOSE
- BENZOIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0295-9003 | 0295-9003-12, 0295-9003-17 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CARBOXYMETHYLCELLULOSE | 05JZI7B19X | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 86cead9a-caed-751e-e053-2a91aa0a1a50 | 86cefd91-771f-e4e7-e053-2991aa0a655e | 2019-04-18 | Warnings | 86cead9a-caed-751e-e053-2a91aa0a1a50 86cefd91-771f-e4e7-e053-2991aa0a655e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.