FDA.reportPublic FDA data

Childrens Acetaminophen Oral Suspension

Manufacturer
American Health Packaging
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:28:02

Label at a glance#

ProductChildrens Acetaminophen Oral Suspension
Active ingredientACETAMINOPHEN
Label structure17 sections

Indications and uses

reduces fever 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 take more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 under 2...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL)
Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Usestemporarily:

INDICATIONS & USAGE SECTION

  • reduces fever
  • 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 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 has liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose Warning:

OVERDOSAGE SECTION

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 sign or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 unit dose cup)

36-47

4-5 years

7.5 mL (1.5 unit dose cups)

48-59

6-8 years

10 mL (2 unit dose cups)

60-71

9-10 years

12.5 mL (2.5 unit dose cups)

72-95

11 years

15 mL (3 unit dose cups)

* or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium: 2 mg
  • Store at 20° to 25°C (68° to 77°F)

    grape flavored suspension supplied in the following oral dosage form:
    5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-762-17

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

SPL UNCLASSIFIED SECTION

DO NOT USE IF SEAL IS BROKEN.

Distributed by:
American Health Packaging
Columbus, OH 43217

T0966C050423
R04/23

Principal Display Panel – Tray – 160 mg/5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160 mg/5 mL Children’s Acetaminophen Oral Suspension Tray Label160 mg/5 mL Children’s Acetaminophen Oral Suspension Tray Label

Case NDC 60687-762-17/Cup NDC 60687-762-40

Children’s Acetaminophen
Oral Suspension
160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only.

T0966C050423            R04/23

Principal Display Panel – Cup – 160 mg/5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160 mg/5 mL Children’s Acetaminophen Oral Suspension Cup
160 mg/5 mL Children’s Acetaminophen Oral Suspension Cup

NDC 60687- 762-40

CHILDREN’S
ACETAMINOPHEN
ORAL SUSPENSION

Pain Reliever-Fever Reducer

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free

Delivers 5 mL

SHAKE WELL BEFORE USING

See package Drug Facts inert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0966C50423

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN2
307668acetaminophen 32 MG/ML Oral SuspensionSCD2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY2
307668APAP 32 MG/ML Oral SuspensionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-762-17Childrens Acetaminophen Oral Suspension10 in 1 CASESUSPENSION102
60687-762-40Childrens Acetaminophen Oral Suspension5 mL in 1 CUP, UNIT-DOSESUSPENSION52
60687-762-46Childrens Acetaminophen Oral Suspension10 in 1 TRAYSUSPENSION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-762CHILDRENS ACETAMINOPHEN ORAL SUSPENSION (ACETAMINOPHEN) SUSPENSION [AMERICAN HEALTH PACKAGING]2Current NDC, 3 package rows20241023_8231dd91-e9e6-4350-a485-fa95d65a6d25.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-762-17ML - Milliliter60687-762c3d44cf4-acf0-4f34-a30d-749cc7399aa112023-08-08
60687-762-40ML - Milliliter60687-762217cee6a-990f-4e51-b0b2-28db5932e29112023-08-08

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60687-76260687-762-40, 60687-762-46, 60687-762-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
BUTYLPARABEN3QPI1U3FV8IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Acetaminophen Oral SuspensionACETAMINOPHENAmerican Health Packaging8231dd91-e9e6-4350-a485-fa95d65a6d252024-10-21WarningsExact identifier
ndc (package): 60687-762-40
ndc (package): 60687-762-17
ndc (package): 60687-762-46
ndc (product): 60687-762
ndc11 (package): 60687076240
ndc11 (package): 60687076246
ndc11 (package): 60687076217
spl id: 24ffe677-36c2-566c-e063-6394a90a7c00
spl set id: 8231dd91-e9e6-4350-a485-fa95d65a6d25

Reported adverse events (FAERS/openFDA)#

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