Indications and uses
temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache
Fridababy Children Pain and Fever Acetaminophen 160mg per 5mL vial 10ct
- Manufacturer
- Fridababy LLC
- Effective date
- 2023-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:17:38
Label at a glance#
ProductFridababy Children Pain and Fever Acetaminophen 160mg per 5mL vial 10ct
Active ingredientACETAMINOPHEN
Label structure9 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) ■ use the chart below to confirm dose. If possible, use weight to dose, otherwise, use age. ■ give the recommended number of vials below. To open, follow the instructions under How to Use. ■ if needed, repeat dose every 4 hours while symptoms last. ■ do not give more than 5 times in...
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient (in each 5mL)
Acetaminophen, 160mg
Purpose
Pain reliever/fever reducer
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 for this product
■ with other drugs containing acetaminophen.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away
Sore throat warning: if sore throat is severe, persistent 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.
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.
OVERDOSAGE SECTION
In case of accidental 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 or symptoms.
Directions
■ this product does not contain directions or complete warnings for adult use
■ do not give more than directed (see overdose warning)
■ use the chart below to confirm dose. If possible, use weight to dose, otherwise, use age.
■ give the recommended number of vials below. To open, follow the instructions under How to Use.
■ 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 (lbs) | Age (Years) | Dose |
| under 24 lbs. | under 2 years | Ask a doctor |
| 24-35 lbs. | 2 - 3 years | 1 Single Use Vial (5 mL) |
| 36-47 lbs. | 4-5 years | Ask a doctor |
| 48-71 lbs. | 6-10 Years | 2 Single Use Vial (10 mL) |
| 72-95 lbs | 11 years | 3 Single Use Vial (15 mL) |
Other Information
■ Each Single Use Vial contains 8mg of sodium
■ Store at 68-77°F (20-25°C)
■ Tamper Evident: do not use if the pouch is damaged, open or broken. Do not use if any vial is open or broken.
Inactive Ingredient
citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.
Questions or Comments?
1-833-WTF-FRIDA (1-833-983-3743)
Package
Products#
Every source-derived product name is available through these pages.
- Fridababy Children Pain and Fever Acetaminophen 160mg per 5mL vial 10ct
- Acetaminophen 160mg per 5mL
- ACETAMINOPHEN
- MALTITOL
- CITRIC ACID MONOHYDRATE
- WATER
- SUCRALOSE
- SORBITOL
- PROPYLENE GLYCOL
- SODIUM BENZOATE
- XANTHAN GUM
- EDETATE DISODIUM
- SODIUM METABISULFITE
- TRISODIUM CITRATE DIHYDRATE
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72705-124 | 72705-124-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MALTITOL | D65DG142WK | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBITOL | 506T60A25R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | 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 |
|---|---|---|---|---|---|---|
| 0cdf002b-72f7-a399-e063-6294a90a7e02 | e42dc876-b35b-bf1e-e053-2a95a90a884b | 2023-12-19 | Warnings | 0cdf002b-72f7-a399-e063-6294a90a7e02 e42dc876-b35b-bf1e-e053-2a95a90a884b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.