DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (80 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Hydroxypropyl Betadex Hypromellose, Unspecified Fd&c Yellow No. 6 Orange Peppermint Polysorbate 80 Pullulan Sodium Carbonate Sucralose Xylitol Ammonium Glycyrrhizate Hydroxypropyl Corn Starch (5% Substitution By Weight)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-25

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 80 mg

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

Active Ingredient (in Each Strip)

Acetaminophen 80 mg

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

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

Structured Label Content

Uses

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

Purpose

Pain reliever/fever reducer

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 (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 (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? (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

Active Ingredient (in Each Strip) (Active ingredient (in each strip))

Acetaminophen 80 mg

Package Label.principal Display Panel (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

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ flu ■ the common cold ■ headache ■ sore throat ■ toothache", "Purpose": "Pain reliever/fever reducer", "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", "Active ingredient (in each strip)": "Acetaminophen 80 mg", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information