Children Acetaminophen Oral Solution

Manufacturer
ATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONS
Effective date
2024-04-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:15

Label at a glance#

ProductChildren Acetaminophen Oral Solution
Active ingredientACETAMINOPHEN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

Purpose

Pain Reliever/Fever Reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:

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

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.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have liver disease.

Ask a doctor before use if you are taking the blood thinning drug warfarin.

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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.

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. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • find dose in chart below
  • if possible, use weight to dose, otherwise use age
  • dosage may be repeasted every 4 hours, or as directed by a doctor
  • do not give more than 5 doses in 24 hours
 Weight (lbs) under 24 24-35 36-4748-59  60-71 72-95 over 95
Age (years)  under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult
Dosage Teaspoonful (tsp)  consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL)

INACTIVE INGREDIENT SECTION

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN3
307675acetaminophen 32 MG/ML Oral SolutionSCD3
307675acetaminophen 160 MG per 5 ML Oral SolutionSY3
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY3
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY3
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY3
307675APAP 32 MG/ML Oral SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-7014-12026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-22026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-32026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-42026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-52026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-62026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-72026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-82026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-92026-01-29C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-12024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-22024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-32024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-42024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-52024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-62024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-72024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-82024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-92024-04-19C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-12022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-22022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-32022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-42022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-52022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-62022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-72022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-82022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c
17856-7014-92022-01-28C16284748780-1d6a99b39-a174-a426-e053-dadaa90af4c2bda0d08a-042d-4430-bd88-1a44f607b71c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-7014-1Children Acetaminophen Oral Solution5 mL in 1 CUP, UNIT-DOSELIQUID53
17856-7014-1Children Acetaminophen Oral Solution72 in 1 BOX, UNIT-DOSELIQUID723
17856-7014-2Children Acetaminophen Oral Solution48 in 1 BOX, UNIT-DOSELIQUID483
17856-7014-2Children Acetaminophen Oral Solution5 mL in 1 SYRINGELIQUID53
17856-7014-3Children Acetaminophen Oral Solution50 in 1 BOX, UNIT-DOSELIQUID503
17856-7014-3Children Acetaminophen Oral Solution15.6 mL in 1 CUP, UNIT-DOSELIQUID15.63
17856-7014-4Children Acetaminophen Oral Solution2.5 mL in 1 SYRINGELIQUID2.53
17856-7014-4Children Acetaminophen Oral Solution120 in 1 BOX, UNIT-DOSELIQUID1203
17856-7014-5Children Acetaminophen Oral Solution1.25 mL in 1 SYRINGELIQUID1.253
17856-7014-5Children Acetaminophen Oral Solution120 in 1 BOX, UNIT-DOSELIQUID1203
17856-7014-6Children Acetaminophen Oral Solution120 in 1 BOX, UNIT-DOSELIQUID1203
17856-7014-6Children Acetaminophen Oral Solution2.5 mL in 1 SYRINGELIQUID2.53
17856-7014-7Children Acetaminophen Oral Solution20.31 mL in 1 CUP, UNIT-DOSELIQUID20.313
17856-7014-7Children Acetaminophen Oral Solution50 in 1 BOX, UNIT-DOSELIQUID503
17856-7014-8Children Acetaminophen Oral Solution31.2 mL in 1 CUP, UNIT-DOSELIQUID31.23
17856-7014-8Children Acetaminophen Oral Solution50 in 1 BOX, UNIT-DOSELIQUID503
17856-7014-9Children Acetaminophen Oral Solution72 in 1 BOX, UNIT-DOSELIQUID723
17856-7014-9Children Acetaminophen Oral Solution10.15 mL in 1 CUP, UNIT-DOSELIQUID10.153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-7014CHILDREN ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 18 package rows20240420_bda0d08a-042d-4430-bd88-1a44f607b71c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7014-16ML - Milliliter0904-7014fde87ac6-229a-4749-8cae-65366a4b0e4f12019-11-12
0904-7014-20ML - Milliliter0904-7014a0a63714-8c01-42e1-ade2-5f84780549ab12019-11-12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
ndc (product): 0904-7014
62d78fb0-c1bb-4757-bb18-a899856dd6b0bda0d08a-042d-4430-bd88-1a44f607b71c2024-04-19WarningsExact identifier
spl id: 62d78fb0-c1bb-4757-bb18-a899856dd6b0
spl set id: bda0d08a-042d-4430-bd88-1a44f607b71c

Reported adverse events (FAERS/openFDA)#

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