Childrens Acetaminophen

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient (in each 5 mL teaspoonful)

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 pain due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

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; tsp = teaspoonful
• find the 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 tsp)*
Under 24	Under 2	Ask a doctor
24-35	2-3 years	5 mL (1 tsp)
36-47	4-5 years	7.5 mL (1 ½ tsp)
48-59	6-8 years	10 mL (2 tsp)
60-71	9-10 years	12.5 mL (2 ½ tsp)
72-95	11 years	15 mL (3 tsp)

* or as directed by a doctor

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

Sore throat warning

SPL UNCLASSIFIED SECTION

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 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 the 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 the reach of children.

Overdose warning

SPL UNCLASSIFIED 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

Other information

STORAGE AND HANDLING SECTION

• sodium content: 2 mg/5 mL
• store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]
• protect from freezing
• a red, berry flavored suspension supplied in the following oral dosage form: NDC 0121-1781-05 (unit dose cups of 5 mL).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame K, butylparaben, citric acid, corn syrup, FD&C Red No. 40, flavoring, glycerin, 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.

You may also report serious side effects to this phone number.

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL
NDC 0121-1781-05

CHILDREN'S
ACETAMINOPHEN
ORAL SUSPENSION
160 mg/5 mL

Alcohol Free / Aspirin Free
SHAKE WELL

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
Greenville, SC 29605

SEE INSERT

A17810501

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

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

• Childrens Acetaminophen
• Acetaminophen
• acesulfame potassium
• Butylparaben
• Citric Acid Monohydrate
• corn syrup
• FD&C Red No. 40
• glycerin
• Polysorbate 80
• Propylene Glycol
• Water
• Sodium Benzoate
• sorbitol
• Magnesium Aluminum Silicate
• Xanthan Gum

NDC Codes#

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

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 · 24 matching rows.

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.

Reported adverse events (FAERS/openFDA)#

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