FDA Label for Calmour Childrens Acetaminophen Strips Chewable
View Indications, Usage & Precautions
Calmour Childrens Acetaminophen Strips Chewable Product Label
The following document was submitted to the FDA by the labeler of this product Calmour. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
- skin reddening
- blisters
- rash
- 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.
- 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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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:
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:
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
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
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)
* Please review the disclaimer below.
