KROGER CHILDREN PAIN PLUS FEVER CHEWABLES- acetaminophen tablet, chewable

Kroger Children Pain plus Fever chewables by

Drug Labeling and Warnings

Kroger Children Pain plus Fever chewables by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

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
• ▪ blister
• ▪ 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 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.

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

• ▪ 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.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. 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 give more than directed (see overdose warning)
• ▪ chew or crush tablets completely before swallowing
• ▪ 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)	under 24	24-35	36-47	48-59	60-71	72-95
Age (yr)	under 2 years	2-3 years	4-5 years	6-8 years	9-10 years	11 years
Dose (Tablets)	ask a doctor	1 tablet	1 ½ tablets	2 tablets	2 ½ tablets	3 tablets

*or as directed by a doctor

Other information

• ▪ store at room temperature. Avoid high humidity. Protect from light
• ▪ see end flap for expiration date and lot number

Inactive ingredients

citric acid, crospovidone, D&C Red No. 30 Lake, dextrose, FD&C Blue No. 1 Lake, flavors, hydroxypropyl cellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethyl cellulose, starch, sucralose

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC: 41226-061-24

Compare to active ingredient in Children’s Tylenol® Chewables*

Children’s Pain + Fever Chewables

ACETAMINOPHEN 160mg Per Tablet

Pain Reliever/Fever Reducer

• Aspirin free
• Ibuprofen Free

Chew or crush tablets completely before swallowing
Ages 2-11

Grape Flavor

Naturally and Artificially Flavored

24 CHEWABLE TABLETS 160 mg each

TAMPER EVIDENT:DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark children’s Tylenol® Chewable.

DIST. BY:

INGREDIENTS AND APPEARANCE

KROGER CHILDREN PAIN PLUS FEVER CHEWABLES 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-061
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	GRAPE	Imprint Code	RP160
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-061-24	4 in 1 CARTON	04/08/2024
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/08/2024

Labeler - KROGER COMPANY (006999528)