CVS Pharmacy, Inc. Infants' Pain & Fever Drug Facts

Manufacturer
CVS Pharmacy
Effective date
2026-09-03
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-09-11 03:01:42

Label at a glance#

Productinfants pain and fever
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...

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 - ASK DOCTOR SECTION

  • new symptoms occur
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • 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

SPL UNCLASSIFIED SECTION

  • store at 20-25ºC (68-77ºF)
  • 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

CVS™

Ages 2-3 years

Cherry Flavor

Infants’

PAIN & FEVER

Acetaminophen 160 mg / 5 mL, Oral Suspension

Pain Reliever, Fever Reducer

Compare to Infants’ Tylenol® active ingredient

Free of: Aspirin, Ibuprofen & Gluten

No Added Alcohol

DYE FREE

2 FL OZ (59 mL)

Use only with enclosed syringe.

See side panel for more information.

590-17-infants-pain-and-fever.jpg
590-17-infants-pain-and-fever.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-590-10ML - Milliliter59779-590b3aefd34-952f-4883-a470-6e51c3f1c3b812019-12-10
59779-590-16ML - Milliliter59779-5906a643d92-775a-4564-b598-4e0b7309d72012019-12-10
59779-590-26ML - Milliliter59779-590fd201fc1-bf62-47e8-9f31-0d0289d4458012019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB5052
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3112
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJ2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6X2
SORBITOLINACTIVE INGREDIENT506T60A25R2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD42
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-59059779-590-16, 59779-590-10, 59779-590-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-08-17full-release2026-06-01 00:18:13

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 2 · 72 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
24 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
24 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
8 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
8 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
24 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
8 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
24 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
24 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
24 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
8 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
8 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
24 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
24 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
8 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 pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsExact identifier
ndc (package): 59779-590-26
ndc (package): 59779-590-16
ndc (package): 59779-590-10
ndc (product): 59779-590
ndc11 (package): 59779059026
ndc11 (package): 59779059010
ndc11 (package): 59779059016
spl id: a34699ac-20ae-4ca6-a2c0-20003a0c42e7
spl set id: 53b06c48-598e-41ad-ac7a-5508c195535c

Reported adverse events (FAERS/openFDA)#

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