Calmour Childrens Acetaminophen Strips Chewable ACETAMINOPHEN ORAL CALMOUR FDA Approved Drug Facts
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each strip) Acetaminophen 80 mg
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.
Strengths
80 mg
Treats Conditions
Uses Temporarily Reduces Fever Relieves Minor Aches And Pains Due To Flu The Common Cold Headache Sore Throat Toothache

Identifiers & Packaging

Container Type BOX
UPC
0850053563102 0850053563119
UNII
362O9ITL9D
Packaging

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 1 Chewable Strip 24 STRIPS 36 STRIPS

Package Descriptions
  • 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 1 Chewable Strip 24 STRIPS 36 STRIPS

Overview

Drug Facts

Indications & Usage

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

Dosage & Administration

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 image

Warnings & Precautions
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.
Purpose

Purpose Pain reliever/fever reducer

Keep Out of Reach of Children

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


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