Label: ALAHISTDM DM- dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
- NDC Code(s): 50991-826-15, 50991-826-16
- 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 April 24, 2019
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredients
Do not exceed recommended dosage.
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 breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
- new symptoms occur
Do not exceed recommended dosage.
years of age
1 teaspoonful (5 mL)
every 4 to 6 hours,
not to exceed 6
teaspoonfuls in a 24
Children 6 to
under 12 years
(2.5 mL) every 4 to 6
hours, not to exceed
3 teaspoonfuls in 24 hours
6 years of age:
Consult a doctor.
- Other information
- Inactive ingredients
- Questions? Comments?
PRINCIPAL DISPLAY PANEL
The packaging below represents the labeling currently used.
Principal Display Panel and Side Panel for 473 mL Label:
Antihistamine • Antitussive
Each 5 mL (1 teaspoonful) contains:
Dexbrompheniramine Maleate........... 2 mg
Dextromethorphan HBr............... 15 mg
Phenylephrine HCl.................... 7.5 mg
SUGAR FREE / ALCOHOL FREE
DYE FREE / GLUTEN FREE
Owens Cross Roads, AL 35763
16 fl oz. (473 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container with a child-resistant cap.
THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.
Distributed by: Poly Pharmaceuticals, Owens Cross Roads, AL 35763
INGREDIENTS AND APPEARANCE
dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-826 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 2 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 7.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50991-826-15 12 in 1 TRAY 09/01/2016 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:50991-826-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/01/2016 Labeler - Poly Pharmaceuticals, Inc. (198449894) Establishment Name Address ID/FEI Business Operations Monarch PCM, LLC 080000294 manufacture(50991-826)