FDA.reportPublic FDA data

ALAHIST DM

Manufacturer
Poly Pharmaceuticals, Inc.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:19:35

Label at a glance#

ProductALAHIST DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, PHENIRAMINE MALEATE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonful (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in a 24 hours Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours Children under 6 years of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ALAHIST DM LIQUID

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)
Dextromethorphan HBr............... 10 mg
Pheniramine Maleate.............. 12.5 mg
Phenylephrine HCl...................... 5 mg

Purpose

OTC - PURPOSE SECTION

Antitussive

Antihistamine

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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
  • diabetes

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and

children 12

years of age

and over: 		2 teaspoonful (10 mL)

every 4 to 6 hours,

not to exceed 12

teaspoonfuls in a 24

hours
Children 6 to

under 12 years

of age: 		1 teaspoonful

(5 mL) every 4 to 6

hours, not to exceed

6 teaspoonfuls in 24 hours
Children under

6 years of age:
Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified water, Sucralose,Sorbitol

Questions? Comments?

OTC - QUESTIONS SECTION

Serious side effects associated with use of this product may be reported to this number.

Call 1-800-882-1041

Mon. - Fri. (8 a.m. to 5 p.m. CST).

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2639752dextromethorphan HBr 10 MG / pheniramine maleate 12.5 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN6
2639752dextromethorphan hydrobromide 2 MG/ML / pheniramine maleate 2.5 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD6
2639752dextromethorphan hydrobromide 10 MG / pheniramine maleate 12.5 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-444-15ALAHIST DM15 mL in 1 BOTTLELIQUID156
50991-444-16ALAHIST DM473 mL in 1 BOTTLELIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-444-16ML - Milliliter50991-444f6f7a2a1-78f3-4d19-8da5-14737258404d12023-07-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-44450991-444-16, 50991-444-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
POTASSIUM CITRATEEE90ONI6FFIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PHENIRAMINE MALEATENYW905655BACTIB
METHYLPARABENA2I8C7HI9TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALAHIST DMDEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.fdaa062d-110e-798d-e053-6394a90a755c2025-12-03WarningsExact identifier
ndc (package): 50991-444-15
ndc (package): 50991-444-16
ndc (product): 50991-444
ndc11 (package): 50991044415
ndc11 (package): 50991044416
spl id: 4513dc1c-4884-da07-e063-6294a90a6450
spl set id: fdaa062d-110e-798d-e053-6394a90a755c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.