Childrens Pain Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL, 1 teaspoon)

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

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

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 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 the child is taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

• do not exceed recommended dosage (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Overdose Warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. 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
• shake well before using
• find right dose on chart below. If possible, use weight to dose: otherwise, use age.
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device
• tsp = teaspoon, mL = milliliter
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor

Weight (lb)	Age (yr)	Dose (tsp or mL)
under 24	under 2	ask a doctor
24-35	2-3	1 tsp or 5 mL
36-47	4-5	1½ tsps or 7.5 mL
48-59	6-8	2 tsps or 10 mL
60-71	9-10	2½ tsps or 12.5 mL
72-95	11	3 tsps or 15 mL

Other information

STORAGE AND HANDLING SECTION

• store at controlled room temperature
• dosage cup provided
• each teaspoon contains: sodium 2 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose, FD & C Red # 40, Flavors, Glycerin, High Fructose Corn Syrup, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol 1450, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sorbitol Solution, Sucralose Powder, Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

1-732-249-6363

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-103-04

Premier
Value ^®

Children's
Pain Relief
PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
SUSPENSION DROPS

• Alcohol Free
• Aspirin Free
• Ibuprofen Free

Cherry
Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

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Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

• Childrens Pain Relief
• Acetaminophen
• Xanthan Gum
• Carboxymethylcellulose
• Cellulose, Microcrystalline
• Methylparaben
• Propylparaben
• Sucralose
• Saccharin Sodium
• Propylene Glycol
• Polyethylene Glycol 1450
• High Fructose Corn syrup
• Glycerin
• Sorbitol
• FD&C Red No. 40
• Water

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

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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 9 · 507 matching rows.

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Reported adverse events (FAERS/openFDA)#

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