FDA Label for Caring Mill Childrens Cough Dm
View Indications, Usage & Precautions
Caring Mill Childrens Cough Dm Product Label
The following document was submitted to the FDA by the labeler of this product Fsa Store Inc.. 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 5 Ml)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide
Purpose
Cough suppressant
Uses
temporarily relieves
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants• the impulse to cough to help you get to sleep
Do Not Use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
Ask A Doctor Before Use If You Have
• chronic cough that lasts as occurs with smoking, asthma or emphysema• cough that occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor If
• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.• cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• shake bottle well before use• measure only with dosing cup provided• do not use dosing cup with other products• dose as follows or as directed by doctor
adults and children 12 years of age and over | 10 mL every 12 hours, not to exceed 20 mL in 24 hours |
children 6 to under 12 years of age | 5 mL every 12 hours, not to exceed 10 mL in 24 hours |
children 4 to under 6 years of age | 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours |
children under 4 years of age | do not use |
Other Information
• each 5 mL contains: sodium 5 mg• store at 20° to 25°C (68° to 77°F)• dosing cup provided
Inactive Ingredients
D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, glycerin, high fructose corn syrup, methylparaben, natural and artificial orange flavor, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
caring mill™
Compare to the active ingredient of Children’s Delsym®
Ages 4 and Older
Children’s Cough DM
Dextromethorphan Polistirex Extended-Release Oral Suspension
Cough Suppressant
12-Hour Cough Relief
Orange-Flavored Liquid For Children & Adults
Contains No Fever Reducer or Pain Reliever
Day or Night
Alcohol-Free
Dosing Cup Included
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions
5 FL OZ (148 mL)
* Please review the disclaimer below.