FDA.reportPublic FDA data

Calmour Childrens Acetaminophen Strips

Manufacturer
Calmour | Shilpa Medicare Limited, Unit-VI
Effective date
2025-02-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:13

Label at a glance#

ProductCalmour Childrens Acetaminophen Strips Chewable
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredient (in each strip)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 80 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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
Directions
Directions
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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

GENERAL PRECAUTIONS SECTION

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
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

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
CARTON LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2705808acetaminophen 80 MG Oral FilmPSN1
2705808acetaminophen 80 MG Oral FilmSCD1
2705808acetaminophen 80 MG Oral StripSY1
2705808APAP 80 MG Oral FilmSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82918-006-01Calmour Childrens Acetaminophen StripsChewable1 in 1 POUCHSTRIP11
82918-006-24Calmour Childrens Acetaminophen StripsChewable24 in 1 CARTONSTRIP241
82918-006-36Calmour Childrens Acetaminophen StripsChewable36 in 1 CARTONSTRIP361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82918-006CALMOUR CHILDRENS ACETAMINOPHEN STRIPS CHEWABLE (ACETAMINOPHEN ORAL CHEWABLE 80 MG) STRIP [CALMOUR]1Current NDC, 3 package rows20250228_ae47b027-4f29-45bb-a8bd-812978932835.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82918-00682918-006-01, 82918-006-36, 82918-006-24

Ingredients#

Every source-derived ingredient row is available through these pages.

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

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ORANGE5EVU04N5QUIACT
PEPPERMINTV95R5KMY2BIACT
POLYSORBATE 806OZP39ZG8HIACT
PULLULAN8ZQ0AYU1TTIACT
SODIUM CARBONATE45P3261C7TIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)9M44R3409AIACT

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
ndc (package): 82918-006-24
ndc (package): 82918-006-36
ndc (package): 82918-006-01
ndc (product): 82918-006
ndc11 (package): 82918000601
ndc11 (package): 82918000624
ndc11 (package): 82918000636
spl id: 2a5a0639-c514-472f-89ac-6baf8ae2f5f0
spl set id: ae47b027-4f29-45bb-a8bd-812978932835

Reported adverse events (FAERS/openFDA)#

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