OTC Medication Information: Pain Relief Childrens Dye Free

PAIN RELIEF CHILDRENS DYE FREE- acetaminophen suspension
H E B

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily reduces fever
• temporarily relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

Warnings

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

• 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

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product,

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Keep out of reach of children.

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• 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
• use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• 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
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

Weight (lb)	Age (year)	Dose (mL)*
under 24	under 2	ask a doctor
24-35	2-3	5 mL
36-47	4-5	7.5 mL
48-59	6-8	10 mL
60-71	9-10	12.5 mL
72-95	11	15 mL

*or as directed by a doctor

Other information

• each 5 mL contains:sodium 2 mg
• store between 20-25ºC (68-77ºF)
• do not refrigerate
• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Children’s Tylenol® Oral Suspension active ingredient**

Children’s Pain Relief

Acetaminophen 160 mg per 5 mL

Oral Suspension

Pain Reliever / Fever Reducer

For Ages 2 to 11 years

• Alcohol free
• Aspirin free
• Ibuprofen free

FL OZ (mL)

GRAPE FLAVOR

DYE FREE

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Tylenol® Oral Suspension

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

MADE WITH PRIDE AND CARE FOR

H-E-B®, SAN ANTONIO, TX 78204

Product Label

H-E-B Children’s Pain Relief Grape Flavor

PAIN RELIEF CHILDRENS DYE FREE acetaminophen suspension

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-285 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM

Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37808-285-04 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC 1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (37808-285-04)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/30/2017

Labeler — H E B (007924756)

Revised: 03/2023 H E B