Label: ZICAM COUGH MAX- dextromethorphan hydrobromide spray
- NDC Code(s): 62750-016-10
- Packager: Matrixx Initiatives, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each 0.25 mL spray)
Dextromethorphan HBr 6.0 mgClose
temporarily relieves cough due to minor throat and bronchial irritation associated with a cold.Close
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.
Ask a doctor before use if you have
- cough accompanied by excessive phlegm (mucus).
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Remove safety cap.
- Prime pump by spraying into a tissue.
- Hold close to mouth and depress sprayer fully. Swallow.
12 yrs & older................5 sprays (30.0 mg Dextromethorphan HBr) Children under 12 years of age: DO NOT USE
- Repeat every 6-8 hours, not to exceed 4 doses per day.
- May be followed by water or liquids if desired.
- Inactive ingredients
citric acid, glycerin, hydroxylated lecithin, menthol, natural flavors, polyethylene glycol, polysorbate 60, potassium sorbate, purified water, sucraloseClose
- STORAGE AND HANDLING
Store at room temperature 15°C-29°C (59°F-84°F)
© 2008 Developed and
distributed by Zicam LLC,
Scottsdale, Arizona 85255, a
wholly owned subsidiary of
Matrixx Initiatives, Inc.
All rights reserved.
toll-free or visit us on the
web at www.zicam.com
- PRINCIPAL DISPLAY PANEL - 16.3 mL Bottle Carton
Oral Cough Suppressant Spray
Lasts up to
.55 FL. OZ./16.3 mL
- INGREDIENTS AND APPEARANCE
ZICAM COUGH MAX
dextromethorphan hydrobromide spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62750-016 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide 6 mg in 0.25 mL Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62750-016-10 1 in 1 CARTON 1 16.3 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/03/2005 Labeler - Matrixx Initiatives, Inc. (790037253) Establishment Name Address ID/FEI Business Operations Biozone 555564293 Analysis, Manufacture, Relabel, Repack