Calmour Childrens Acetaminophen Strips Strip
FDA Label NDC 82918-006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Calmour for the product Calmour Childrens Acetaminophen Strips (NDC 82918-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each strip), purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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
    • Image (2a5a0639 C514 472f 89ac 6baf8ae2f5f0 01)

    Image (2a5a0639 C514 472f 89ac 6baf8ae2f5f0 01)

    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

1 Chewable Strip (2a5a0639 C514 472f 89ac 6baf8ae2f5f0 02)

1 Chewable Strip (2a5a0639 C514 472f 89ac 6baf8ae2f5f0 02)

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)

24 Strips (2a5a0639 C514 472f 89ac 6baf8ae2f5f0 03)

24 Strips (2a5a0639 C514 472f 89ac 6baf8ae2f5f0 03)

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)

36 Strips (2a5a0639 C514 472f 89ac 6baf8ae2f5f0 04)

36 Strips (2a5a0639 C514 472f 89ac 6baf8ae2f5f0 04)

CARTON LABEL

* Please review the disclaimer below.