Label: LONG ACTING TUSSIN COUGH GELS- dextromethorphan hydrobromide capsule, gelatin coated
- NDC Code(s): 11822-0442-9
- Packager: Rite Aid
- 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 liquidgel)
Dextromethorphan HBr, USP 15 mgClose
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldClose
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
- a cough that occurs with too much phlegm (mucus)
- a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or presistent headache. 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 (1-800-222-1222) right away.
- do not take more than 8 liquidgels in any 24-hour period
- adults and children 12 years and over: take 2 liquidgels every 6 to 8 hours, as needed
- children under 12 years: do not use
- Other information
- store at 20º-25ºC (68º-77ºF)
- avoid excessive heat above 40ºC (104ºF)
- protect from light
- use by expiration date on package
- Inactive ingredients
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, white edible inkClose
- Principal display panel
*Compare to the active ingredient in Robitussin® CoughGels®
cough relief gels
dextromethorphan HBr 15 mg
relieves coughs for up to 8 hours
12 years & older
liquid-filled capsules you just swallow
(LIQUID FILLED CAPSULES)
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin® CoughGels®.
30 HUNTER LANE
CAMP HILL, PA
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Rite Aid 44-442
- INGREDIENTS AND APPEARANCE
LONG ACTING TUSSIN COUGH GELS
dextromethorphan hbr capsule, gelatin coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0442 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 15 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED Score no score Shape CAPSULE Size 13mm Flavor Imprint Code 033 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0442-9 1 in 1 PACKAGE 1 20 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/24/2006 Labeler - Rite Aid (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(11822-0442) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(11822-0442)