FDA.reportPublic FDA data

Acetaminophen Oral Solution

Manufacturer
Cardinal Health
Effective date
2020-03-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:39:15

Label at a glance#

ProductAcetaminophen Oral Solution
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

• do not take more than directed (see overdose warning ) age dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 2 ...

Storage and handling

■ Each 5 mL contains: sodium 2 mg ■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] ■ keep tightly closed  ■ protect from light ■ a red, cherry flavored solution supplied in the following oral dosage forms: Available: 325 mg/ 10.15 mL per cup Overbagged with 5 x 10.15 mL cups per bag, NDC 55154-9417-5

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

ACETAMINOPHEN 160 mg

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

SPL UNCLASSIFIED SECTION

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are allergic to acetaminophen or any of the inactive ingredients of this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

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.  (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

agedose

adults and children 12 years of age and over

20.3 mL (650 mg) every 4 to 6 hours
not to exceed 6 doses in a 24-hour period

children 6 to under 12 years of age

10.15 mL (325 mg) every 4 hours
not to exceed 5 doses in a 24-hour period

children 4 to under 6 years of age

7.5 mL (240 mg) every 4 hours
not to exceed 5 doses in a 24-hour period

children 2 to under 4 years of age

5 mL (160 mg) every 4 hours
not to exceed 5 doses in a 24-hour period

children under 2 years of age

consult a doctor

Other information

STORAGE AND HANDLING SECTION

■ Each 5 mL contains: sodium 2 mg

■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

■ keep tightly closed  ■ protect from light

■ a red, cherry flavored solution supplied in the following oral dosage forms:

Available:

325 mg/ 10.15 mL per cup

Overbagged with 5 x 10.15 mL cups per bag, NDC 55154-9417-5

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210. You may also report serious side effects to this phone number.

MANUFACTURED BY:

SPL UNCLASSIFIED SECTION

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Distributed by:
Cardinal Health

Dublin, OH 43017

L35681690218

R07/19

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Oral Solution USP

325 mg/10.15 mL

5 x 10.15 mL Cups

bag label
bag label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0657-00ML - Milliliter0121-0657e1717ddd-2220-4c37-bf4c-358cc59233d512017-03-06
0121-0657-05ML - Milliliter0121-06578ed88d7b-7da9-4476-8acb-44b7546ea72912013-02-13
0121-0657-11ML - Milliliter0121-0657a7c14538-cd3f-460a-9934-c44d6cfa1d5612013-02-13
0121-0657-21ML - Milliliter0121-0657da514a8a-21cf-4316-988f-d31df443bed612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SORBITOLINACTIVE INGREDIENT506T60A25R2
SUCROSEINACTIVE INGREDIENTC151H8M5542
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-941755154-9417-5
0121-0657

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

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 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma6ec12573-03d6-40c1-9945-d345b401e0622024-08-12WarningsExact identifier
ndc (product): 0121-0657
f49acabb-3672-408e-b3d9-4bcc95750f772b8a640c-6859-42b3-a5dc-7a7d2a12816c2020-08-09WarningsExact identifier
spl set id: 2b8a640c-6859-42b3-a5dc-7a7d2a12816c

Reported adverse events (FAERS/openFDA)#

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