Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Infants Pain Relief
- Manufacturer
- Chain Drug Consortium (Premier Value) | davAgen Pharmaceutical, LLC
- Effective date
- 2014-10-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:40:47
Label at a glance#
ProductInfants Pain Relief
Active ingredientAcetaminophen
Label structure11 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only the enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe into hole at top of bottle and turn upside down. pull back plunger of syringe until syringe filled s...
Storage and handling
store at controlled room temperature each 5 mL contains: sodium 2 mg
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purposes
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
Sore throat warning: if sore throat is severe, persist 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 non-prescription). 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 is taking the blood thinning drug warfarin.
Ask a Doctor before use if your child has liver disease.
OTC - WHEN USING SECTION
When using this product do not exceed recommended dosage (see overdose warning)
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain gets worse or last more than 5 days.
- fever gets worse or lasts for more than 3 days.
These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all drugs out of reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222). Quick 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
- shake well before using
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- use only the enclosed syringe designed for use with this product. Do not use any other dosing device.
- remove bottle cap and insert syringe into hole at top of bottle and turn upside down.
- pull back plunger of syringe until syringe filled slightly over prescribed level.
Turn to original position, simply push plunger back until you have reached the prescribed level. Pull syringe out of the bottle.
- dispense liquid slowly into baby's mouth, toward the inner cheek.
- if needed repeat dose every 4 hours while symptoms last.
- do not use more than 5 times in 24 hours (see overdose warning).
- replace cap tightly to maintain child resistance.
| Weight (lb) | Age (yr) | Dose (mL) |
|---|---|---|
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
Attention: use only the enclosed syringe designed for use with this product. Do not use any other dosing device.
Other information
- store at controlled room temperature
- each 5 mL contains: sodium 2 mg
Inactive ingredients
Carboxymethylcellulose, Flavor, Glycerin, High Fructose Corn Syrup, Methyl Paraben, Microcrystal Cellulose, Polyethylene Glycol 1450, Propyl Paraben, Propylene Glycol, Purified Water, Saccharin Sodium, Sorbitol, Sucralose, Xanthan Gum
Questions or comments?
1-732-249-6363
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
NDC 68016-160-02
Premier
Value ®
Infants'
Pain Relief
PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
SUSPENSION LIQUID
• Dye Free
• Alcohol Free
• Aspirin Free
Use only with
enclosed syringe
Cherry Flavor
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
2 FL OZ (59 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 1 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 1 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 1 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 1 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68016-160-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e2c7-f424-e053-dadaa90a57ce | Infant's Pain Relief |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-160-02 | Infants Pain Relief | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 68016-160-02 | Infants Pain Relief | 59 mL in 1 BOTTLE, PLASTIC | LIQUID | 59 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-160-02 | ML - Milliliter | 68016-160 | f71b6fee-7f54-478e-9b58-84c5970e8830 | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Carboxymethylcellulose | INACTIVE INGREDIENT | 05JZI7B19X | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| High Fructose Corn syrup | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| Polyethylene Glycol 1450 | INACTIVE INGREDIENT | OJ4Z5Z32L4 | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 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
- Acetaminophen
- Xanthan Gum
- Carboxymethylcellulose
- Cellulose, Microcrystalline
- Methylparaben
- Propylparaben
- Sucralose
- Saccharin Sodium
- Propylene Glycol
- Polyethylene Glycol 1450
- High Fructose Corn syrup
- Glycerin
- Sorbitol
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-160 | 68016-160-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Xanthan Gum | TTV12P4NEE | IACT |
| Carboxymethylcellulose | 05JZI7B19X | IACT |
| Cellulose, Microcrystalline | OP1R32D61U | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Propylparaben | Z8IX2SC1OH | IACT |
| Sucralose | 96K6UQ3ZD4 | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Polyethylene Glycol 1450 | OJ4Z5Z32L4 | IACT |
| High Fructose Corn syrup | XY6UN3QB6S | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Sorbitol | 506T60A25R | IACT |
| Water | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | LIQUID / TOPICAL | 1 %w/w | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| Carboxymethylcellulose | CARBOXYMETHYLCELLULOSE | 05JZI7B19X | SUSPENSION / ORAL | 50.07 mg/5ml | ||
| High Fructose Corn syrup | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SUSPENSION, EXTENDED RELEASE / ORAL | 3000 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 mg | ||
| Carboxymethylcellulose | CARBOXYMETHYLCELLULOSE | 05JZI7B19X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Sorbitol | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAMUSCULAR | 0.02 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| Sorbitol | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| Polyethylene Glycol 1450 | POLYETHYLENE GLYCOL 1450 | OJ4Z5Z32L4 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | LOTION / TOPICAL | 140 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| Carboxymethylcellulose | CARBOXYMETHYLCELLULOSE | 05JZI7B19X | TABLET / ORAL | 45 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FILM COATED / ORAL | 2 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SOFT TISSUE | 0.02 %w/v | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| Sucralose | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v |
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 |
|---|---|---|---|---|---|---|
| 991bcb88-e32d-43c9-86f9-2a9c8af5ed6a | 60476951-a730-4ee6-b270-2f4ac868cfe0 | 2014-10-28 | Warnings | 991bcb88-e32d-43c9-86f9-2a9c8af5ed6a 60476951-a730-4ee6-b270-2f4ac868cfe0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.