FDA.reportPublic FDA data

Rite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts

Manufacturer
Rite Aid Corporation
Effective date
2026-07-24
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-07-28 05:10:10

Label at a glance#

Productinfants fever reducer and pain reliever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache

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 the first dose line and then push...

Storage and handling

• store at 20-25°C (68-77°F) • do not use if printed neckband is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

Warnings

WARNINGS SECTION

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

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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • 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 has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 the first dose line and then push product back into bottle.
  • pull yellow part of syringe until it reaches and stays at the 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

Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

* or as directed by a doctor

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • do not use if printed neckband is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Infants’ Tylenol® Oral Suspension

FREE FROM | DYE FREE

PARABEN FREE

FOR AGES 2-3 YEARS

INFANTS’ FEVER REDUCER & PAIN RELIEVER

ACETAMINOPHEN

160 mg/5 mL

oral suspension

aspirin free

ibuprofen free

GRAPE FLAVOR

2 FL OZ (60 mL)

USE ONLY ENCLOSED SYRINGE

SEE SIDE PANEL FOR MORE INFORMATION

766-83-infants-fever-reducer-and-pain-reliever
766-83-infants-fever-reducer-and-pain-reliever

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0766-12023-11-16C16284748780-1f386c64a-46f8-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-12023-11-16C16284748780-1f386c64a-46f8-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-22023-11-16C16284748780-1f386c64a-46f8-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-22023-11-16C16284748780-1f386c64a-46f8-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-12023-01-30C16284748780-1f386c64a-46f8-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-12023-01-30C16284748780-1f386c64a-46f8-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-22023-01-30C16284748780-1f386c64a-46f8-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts
11822-0766-22023-01-30C16284748780-1f386c64a-46f8-0266-e053-dadaa90a7c1aRite Aid Corporation Infants’ Fever Reducer & Pain Reliever Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D3
ACETAMINOPHENACTIVE MOIETY362O9ITL9D3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB5053
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3113
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJ3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6X3
SORBITOLINACTIVE INGREDIENT506T60A25R3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD43
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-076611822-0766-1, 11822-0766-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CALCIUM SULFATE, UNSPECIFIED FORMWAT0DDB505IACT
CARRAGEENAN5C69YCD2YJIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM PHOSPHATE, TRIBASICA752Q30A6XIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-10-31full-release2026-06-01 00:32:52

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.

Inactive ingredient links page 1 of 1 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
18 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
6 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
18 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
18 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
18 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
18 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
18 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
6 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
6 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
6 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
18 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
18 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
18 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
6 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
18 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
18 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
6 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporation920e7055-7ed1-4db4-9215-f8933078bb7b2026-07-24WarningsExact identifier
ndc (package): 11822-0766-1
ndc (package): 11822-0766-2
ndc (product): 11822-0766
ndc11 (package): 11822076601
ndc11 (package): 11822076602
spl id: ee050134-cf12-4904-92e2-b3f5bfbdd39f
spl set id: 920e7055-7ed1-4db4-9215-f8933078bb7b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.