Indications and uses
Temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
Childrens Dye Free Pain and Fever, 20 Single Doses x 5 mL ea
- Manufacturer
- Walgreens | New Vision Pharmaceuticals LLC
- Effective date
- 2021-03-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:49:13
Label at a glance#
ProductChildrens Dye Free Pain and Fever, 20 Single Doses x 5 mL ea
Active ingredientACETAMINOPHEN
Label structure8 sections
Dosage and administration
• do not give more than directed (see overdose warning) • use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age • give the recommended number of vials below. • empty each Single-Use Vial required of all liquid when dosing • 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...
Storage and handling
each Single-Use Vial contains 6mg of sodium store at 20-25ºC (68-77ºF) tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
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 acetamintophen.
Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.
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.
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
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
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 last more than 5 days
• fever gets worse or last 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
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms. (1-800-222-1222)
Directions
• do not give more than directed (see overdose warning)
• use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age
• give the recommended number of vials below.
• empty each Single-Use Vial required of all liquid when dosing
• 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
• this product does not contain directions or complete warnings for adult use.
• How to Open & Use:
1. Flick the tip before opening so liquid descends.
2. Twist the tip until open and discard immediately.
3. Place open end into child’s mouth and Squeeze to dispense all liquid and discard.
Dosing Chart
| Weight (lbs) | Age (Years | Dose (mL) |
| under 24 lbs | under 2 years | Talk to a doctor |
| 24 - 35 lbs | 2 - 3 years | 1 Single-Use Vial (5 mL) Every 4 hours while symptoms last. Do not exceed 5 Single-Use Vials in 24 hours. |
Other Information
- each Single-Use Vial contains 6mg of sodium
- store at 20-25ºC (68-77ºF)
- tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
Inactive Ingredients
citric acid, edetate disodium, glycerin, grape flavor, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.
Questions or Comments?
+1-800-925-4733
Package Labeling
Products#
Every source-derived product name is available through these pages.
- Childrens Dye Free Pain and Fever, 20 Single Doses x 5 mL ea
- Acetaminophen
- POLYETHYLENE GLYCOL 600
- XANTHAN GUM
- PROPYLENE GLYCOL
- SODIUM METABISULFITE
- WATER
- ANHYDROUS CITRIC ACID
- SODIUM BENZOATE
- SORBITOL SOLUTION 70%
- TRISODIUM CITRATE DIHYDRATE
- MALTITOL
- SUCRALOSE
- EDETATE DISODIUM
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-3464 | 0363-3464-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| WATER | 059QF0KO0R | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION 70% | 8KW3E207O2 | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| MALTITOL | D65DG142WK | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| d42eb1eb-ad82-bbf1-e053-2a95a90a0b56 | a5171ba1-6c2f-737f-e053-2a95a90ad0fe | 2021-12-28 | Warnings | a5171ba1-6c2f-737f-e053-2a95a90ad0fe |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.