Indications and uses
temporarily: ▪ reduces fever ▪ relieves minor aches and pains due to: ▪ the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache
Dye-Free Infants' Pain + Fever Drug Facts
- Manufacturer
- FAMILY DOLLAR SERVICES INC
- Effective date
- 2026-09-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- daily-update
- Hydrated at
- 2026-09-22 03:01:28
Label at a glance#
ProductDye Free Infants Pain and Fever
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 ▪ mL = milliliter ▪ find right dose on chart. If possible, use weight to dose; otherwise, use age. ▪ push air out of syringe. Insert syringe tip into bottle opening ▪ flip bottle upside down. Pull yellow part of syringe to correct dose ▪ dispense liquid ...
Storage and handling
▪ Each 5 mL contains: sodium 2 mg ▪ store at room temperature
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
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
- with other drugs containing acetaminophen
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
Sore throat warning: if sore throat is severe, persists 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose (see overdose warning)
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children 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 (seeoverdose warning)
- shake well before using
- mL = milliliter
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
- push air out of syringe. Insert syringe tip into bottle opening
- flip bottle upside down. Pull yellow part of syringe to correct dose
- dispense liquid slowly into child's mouth, toward inner cheek
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- replace cap tightly to maintain child resistance
| Weight (lb) | Age (yr) | Dose (mL) ** |
|---|---|---|
under 24 | under 2 years | ask a doctor |
24-35 lbs | 2-3 years |
|
SPL UNCLASSIFIED SECTION
Attention: use only enclosed syringe specifically designed for use with this product.
Do not use any other dosing device.
Other information
- Each 5 mL contains: sodium 2 mg
- store at room temperature
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum
Questions?
1-866-467-2748
PRINCIPAL DISPLAY PANEL
Compare to the active ingredient in Dye-Free Infants’ Tylenol® Oral Suspension*
NDC 55319-206-02
Dye-Free
Infants'
Pain + Fever
Acetaminophen
Oral Suspension
Pain Reliever-Fever Reducer
Free Of:
- Dyes
- Ibuprofen
- Aspirin
- Parabens
- High Fructose Corn Syrup
Natural Grape Flavor
No Added Alcohol
Sugar Free
Use Only Enclosed Syringe
2 FL OZ (60 mL)
160 mg per 5 mL***
***Same as Children’s TYLENOL
*This Product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Dye-Free Infants’ Tylenol® Oral Suspension.
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING
IMPORTANT: Keep this carton for future reference on full labeling.
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0032251926150 | GTIN-13: 0032251926150 EAN-13: 0032251926150 GTIN-12: 032251926150 UPC-A: 032251926150 GTIN storage (14 digits): 00032251926150 | tylenol-01.jpg |
Products#
Every source-derived product name is available through these pages.
- Dye Free Infants Pain and Fever
- acetaminophen
- ANHYDROUS CITRIC ACID
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- GLYCERIN
- MICROCRYSTALLINE CELLULOSE
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE, UNSPECIFIED FORM
- SORBITOL SOLUTION
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-206 | 55319-206-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2025-09-25 | full-release | 2026-06-01 01:14:53 |
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 |
|---|---|---|---|---|---|---|
| 3f9d0d42-a975-fd37-e063-6294a90a7143 | c15f745d-1036-46a7-8253-9f75475df3c7 | 2025-09-25 | Warnings | c15f745d-1036-46a7-8253-9f75475df3c7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.