Label: ALAHIST CF- dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet
- NDC Code(s): 50991-784-02, 50991-784-90
- Packager: Poly Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 20, 2020
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- ACTIVE INGREDIENT
Do not exceed recommended dosage.
Do not use this product
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 ifyou have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to enlargement of the prostate gland
- heart disease
- high blood pressure
- thyroid disease
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever
If pregnant or breast-feeding, ask a health
professional before use.
- INACTIVE INGREDIENTS
- OTHER INFORMATION
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-784 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 2 g DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 g Inactive Ingredients Ingredient Name Strength DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TURMERIC (UNII: 856YO1Z64F) Product Characteristics Color yellow Score 2 pieces Shape OVAL Size 11mm Flavor Imprint Code C;F Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50991-784-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/14/2017 2 NDC:50991-784-02 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/14/2017 Labeler - Poly Pharmaceuticals, Inc. (198449894) Establishment Name Address ID/FEI Business Operations Monarch PCM, LLC 080000294 manufacture(50991-784) Establishment Name Address ID/FEI Business Operations Rainbow Gold Products, Inc 800695152 repack(50991-784)