CALMOUR CHILDRENS ACETAMINOPHEN STRIPS CHEWABLE- acetaminophen oral chewable 80 mg strip

Calmour Childrens Acetaminophen Strips by

Drug Labeling and Warnings

Calmour Childrens Acetaminophen Strips by is a Otc medication manufactured, distributed, or labeled by Calmour, Shilpa Medicare Limited, Unit-VI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Children's Acetaminophen Chewable Strips

Drug Facts

Active ingredient (in each strip)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily:  ■  reduces fever  ■  relieves minor aches and pains due to:  ■  flu  ■  the common cold  ■  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: 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 give more than directed (see overdose warning)
• find the right dose on the chart below. If possible, use weight to dose; otherwise, use age.
• remove the strip from the pouch, place in the child's mouth then wait for 45 seconds, and anything remaining can be chewed.
• repeat dose every 4-6 hours while symptoms last
• do not give more than 5 doses in 24 hours

Dosing Chart

Wt: weight; lb: pound; mg: milligram
* or as directed by a doctor
Age in Years	Wt in lbs	Number of strips given every 4-6 hours of acetaminophen 80 mg*
under 2 years	< 24 lbs	consult a doctor
2 to under 4 years	24-35 lbs	2 strips of 80 mg
4 to under 6 years	36-47 lbs	3 strips of 80 mg
6 to under 9 years	48-59 lbs	4 strips of 80 mg

Other information

• store below 77°F (25°C)
• do not refrigerate
• do not use it if the pouch containing strip is open
• see lot number and expiration date on pouch containing strip and box

Inactive ingredients

citric acid anhydrous, glycerin, HP-betacyclodextrin oral, hydroxypropyl methylcellulose, monoammonium glycyrrhizinate, Neelicert FD&C yellow 6, orange flavor, peppermint flavor, polysorbate 80, pregelatinized hydroxypropyl pea starch, pullulan, sodium carbonate, sucralose and xylitol.

Questions or comments?

Call 1-802-861-4111

Monday-Friday, 9 am-5 pm EST

Distributed by:

CALMOUR, LLC

1775 Williston Road

South Burlington, VT 05403

Phone (802) 861-4111

Calmourhealth.com

©2024 Calmour, LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pouch Label

NDC: 82918-006-01

CHILDREN'S ACETAMINOPHEN STRIP

CALMOUR

Acetaminophen 80 mg

1 Chewable Strip

POUCH LABEL

CARTON LABEL

NDC: 82918-006-24

CHILDREN'S ACETAMINOPHEN STRIPS

Oral Chewable Strip

●  Pain Reliever

●  Fever Reducer

●  For Ages 2-9 Years

ACETAMINOPHEN 80 mg

Aspirin Free

Ibuprofen Free

Alcohol Free

24 Strips

(packed individually)

CARTON LABEL

CARTON LABEL

NDC: 82918-006-36

CHILDREN'S ACETAMINOPHEN STRIPS

Oral Chewable Strip

●  Pain Reliever

●  Fever Reducer

●  For Ages 2-9 Years

ACETAMINOPHEN 80 mg

Aspirin Free

Ibuprofen Free

Alcohol Free

36 Strips

(packed individually)

CARTON LABEL

INGREDIENTS AND APPEARANCE

CALMOUR CHILDRENS ACETAMINOPHEN STRIPS  CHEWABLE
acetaminophen oral chewable 80 mg strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82918-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ORANGE (UNII: 5EVU04N5QU)
PEPPERMINT (UNII: V95R5KMY2B)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PULLULAN (UNII: 8ZQ0AYU1TT)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82918-006-36	36 in 1 CARTON	03/01/2025
1	NDC: 82918-006-01	1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 82918-006-24	24 in 1 CARTON	02/25/2025
2	NDC: 82918-006-01	1 in 1 POUCH; 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	02/25/2025

Labeler - Calmour (118597110)

Registrant - Shilpa Medicare Limited, Unit-VI (854193706)

Establishment
Name	Address	ID/FEI	Business Operations
Shilpa Medicare Limited, Unit-VI		854193706	ANALYSIS(82918-006) , MANUFACTURE(82918-006) , PACK(82918-006) , LABEL(82918-006)