Label: FACOL CLASSIC ONE- acetaminophen, guaifenesin, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, cloperastine hydrochloride, chlorpheniramine maleate capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 72689-0013-1 - Packager: OASIS TRADING
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 21, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
When using this product
Do not use for a period longer than 1 weeks
Stop use and ask a doctor if nervousness, dizziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days.
fever gets worse or lasts more than 3 days
New symptoms occur
These may 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 - INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACOL CLASSIC ONE
acetaminophen, guaifenesin, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, cloperastine hydrochloride, chlorpheniramine maleate capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72689-0013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 41.6 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- (UNII: 99214P83XM) (METHYLEPHEDRINE, (+/-)- - UNII:SHS9PGQ2LS) METHYLEPHEDRINE HYDROCHLORIDE, (+/-)- 12.5 mg CLOPERASTINE HYDROCHLORIDE (UNII: PI4N7C63ND) (CLOPERASTINE - UNII:69M5L7BXEK) CLOPERASTINE HYDROCHLORIDE 8 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1.25 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color brown Score no score Shape OVAL Size 22mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72689-0013-1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/22/2018 Labeler - OASIS TRADING (689991468) Registrant - OASIS TRADING (689991468) Establishment Name Address ID/FEI Business Operations OASIS TRADING 689991468 manufacture(72689-0013) , label(72689-0013)
