Indications and uses
temporarily reduces fever relieves minor aches and pains due to: the common cold sore throat flu toothache headache
Infants Pain Relief Oral Suspension Dye-Free
- Manufacturer
- WinCo Foods, LLC
- Effective date
- 2019-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:01:52
Label at a glance#
ProductInfants Pain Relief Dye-Free
Active ingredientACETAMINOPHEN
Label structure8 sections
Dosage and administration
this product does not contain directions or complete warnings for adult dose do not give more than directed (see overdose warning) shake well before use use only enclosed dosing syringe find right dose on chart below remove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level. dispense liquid slowly into childs mouth towards inner cheek repeat dose every 4 hours if needed do not g...
Storage and handling
store between 20-25 o C(68-77 o F)
Label contents#
Full prescribing information#
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
- sore throat
- flu
- toothache
- headache
Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:
- more than 5 doses in 24 hours, which is maximum daily amount
- with other drugs containing acetaminophen
- 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.
Do not use
- with any other drug containing acetaminophen (prescription or non prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
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
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
- redness or swelling is present
- new symptoms occur
- These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. 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 dose
do not give more than directed (see overdose warning)
shake well before use
- use only enclosed dosing syringe
- find right dose on chart below
- remove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level.
- dispense liquid slowly into childs mouth towards inner cheek
- repeat dose every 4 hours if needed
- do not give more than 5 times in 24 hours
- replace the cap tightly to maintain child resistance
- return dispenser to the box after thorough cleaning
| Weight (lb) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
* or as directed by a doctor
Other information
- store between 20-25oC(68-77oF)
Inactive ingredients
citric acid anhydrous, butyl paraben, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum
PDP
*Compare to the active ingredient in Childrens TYLENOL®Suspension
Infants Oral Suspension Pain relief
ACETAMINOPHEN 160 mg per 5 mL
PAIN RELIEVER-FEVER REDUCER
Alcohol Free
Aspirin & Ibuprofen Free
For Ages 2-3 Years
Dye-Free
Cherry Flavor
2 FL OZ (60 mL) 160 mg per 5 mL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 2 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 2 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 2 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 2 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67091-121-60 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5122-a426-e053-dadaa90af4c2 | Infants Pain Relief Oral Suspension Dye-Free |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67091-121-60 | Infants Pain Relief Dye-Free | 1 in 1 CARTON | SUSPENSION | 1 | 2 | |
| 67091-121-60 | Infants Pain Relief Dye-Free | 60 mL in 1 BOTTLE | SUSPENSION | 60 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 50-100 MPA.S AT 1%) | INACTIVE INGREDIENT | 6QM647NAYU | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MALTITOL | INACTIVE INGREDIENT | D65DG142WK | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Infants Pain Relief Dye-Free
- Acteaminophen
- ACETAMINOPHEN
- ANHYDROUS CITRIC ACID
- BUTYLPARABEN
- GLYCERIN
- MALTITOL
- CELLULOSE, MICROCRYSTALLINE
- CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 50-100 MPA.S AT 1%)
- PROPYLPARABEN
- WATER
- SUCRALOSE
- XANTHAN GUM
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67091-121 | 67091-121-60 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / BUCCAL | 30 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | GEL / TOPICAL | 3 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / OPHTHALMIC | 0.09 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM / ORAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / SUBLINGUAL | 36 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | ELIXIR / ORAL | 90 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | TABLET, COATED / ORAL | 0.08 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EFFERVESCENT / ORAL | 840 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | OIL / TOPICAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / TOPICAL | 4 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | LOTION / TOPICAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION/ DROPS / AURICULAR (OTIC) | 1 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 35 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / RECTAL | 0.01 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg |
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 |
|---|---|---|---|---|---|---|
| 68e0dc7a-c649-4785-8e8c-e62de62997a8 | 3ef48abf-a6fb-4192-a8b2-486cc8d67112 | 2019-12-09 | Warnings | 68e0dc7a-c649-4785-8e8c-e62de62997a8 3ef48abf-a6fb-4192-a8b2-486cc8d67112 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.