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.
Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
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 Remove cap, insert 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...
Drug Facts
Acetaminophen 160mg
Pain Reliever/Fever Reducer
Temporarily:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
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.
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
if your child has liver disease.
if your child is taking the blood thinning drug warfarin.
do not exceed recommended dosage (see 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.
This product does not contain directions or complete warnings for adult use.
mL = mililiter
| Weight (lbs) | Age (yrs) | Dose |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 5 mL |
citric acid, glycerin, natural grape flavor, potassium sorbate, povidone, propylene glycol, purified water, sodium citrate, sucralose, sucrose, xanthan gum
1-800-54-8853 Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST
LittleRemedies.com
Little Remedies®
INFANT
FEVER + PAIN RELIEVER
Acetaminophen 160 mg / 5 mL
natural grape flavor
2 FL OZ (59 mL)
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CITRIC ACID | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63029-611 | 63029-611-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY / NASAL | 2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAVENOUS | 864 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / OPHTHALMIC | 0.03 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GUM, CHEWING / BUCCAL | 70 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ENEMA / RECTAL | 60 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRATHECAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / TOPICAL | 0.01 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAVENOUS | 10 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION, EMULSION / INTRAVENOUS | 0.1 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION, EXTENDED RELEASE / ORAL | 140.8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO, SUSPENSION / TOPICAL | 0.25 %w/v | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| CITRIC ACID | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w |
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 |
|---|---|---|---|---|---|---|
| 14c8a38b-a747-4ae7-9750-3a1a715a1377 | 7a542263-c5cf-449c-9527-71a50bf07cbb | 2020-07-20 | Warnings | 14c8a38b-a747-4ae7-9750-3a1a715a1377 7a542263-c5cf-449c-9527-71a50bf07cbb |
Adverse event summaries are temporarily unavailable. Other product information remains available.