FDA.reportPublic FDA data

Alahist CF Tablets

Manufacturer
Poly Pharmaceuticals, Inc. | Monarch PCM, LLC
Effective date
2022-11-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:42

Label at a glance#

ProductAlahist CF
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE 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:  relieves cough  runny nose  sneezing  itching of the nose or throat  itchy, watery eyes  nasal congestion  reduces swelling of nasal passages

Dosage and administration

Directions Adults and children 12 years of age and over 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age 1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet) Purpose

Dexbrompheniramine Maleate 2 mg​

Antihistamine
Dextromethorphan Hydrobromide 20 mgCough Supressant
Phenylephrine HCl 10mgNasal Decongestant

USES

INDICATIONS & USAGE SECTION

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

  •  relieves cough
  •  runny nose
  •  sneezing
  •  itching of the nose or throat
  •  itchy, watery eyes
  •  nasal congestion 
    • reduces swelling of nasal passages

WARNINGS

WARNINGS SECTION

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
  •  glaucoma
  •  trouble urinating due to enlargement of the prostate gland
  •  heart disease
  •  high blood pressure
  •  thyroid disease 
  • diabetes

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and over1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
Children 6 to under 12 years of age1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients
Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Natural Yellow, Pregelatinized Starch, Silicon Dioxide

QUESTIONS

OTC - QUESTIONS SECTION

Questions? Comments?
Call 1-800-882-1041
Manufactured for:
Poly Pharmaceuticals
Huntsville, AL 35763 Rev. 04/17

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information
Store at 15°-30°C (59°-86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Alahist CF Tablets are light yellow,caplet-shaped, scored tablets, debossed "C" bisect "F" on one side and plain on the other.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children

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

OTC - PURPOSE SECTION

Antihistamine

Cough Suppressant

Nasal Decongestant

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALAHISTlabelALAHISTlabellabelbookletlabelbooklet

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-784-02Alahist CF12 in 1 BLISTER PACKTABLET124
50991-784-90Alahist CF90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-784ALAHIST CF (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20221119_59774c8a-deaf-53a6-e053-2991aa0a709f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-784-90EA - Each50991-7843372b25e-95ea-41a2-b44b-4e7bfaca241112017-10-13

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
50991-78450991-784-90, 50991-784-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
TURMERIC856YO1Z64FIACT
DEXTROSEIY9XDZ35W2IACT
DEXBROMPHENIRAMINE MALEATEBPA9UT29BSACTIB
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
edb5015d-f063-5d1d-e053-2a95a90ab16d59774c8a-deaf-53a6-e053-2991aa0a709f2022-11-17WarningsExact identifier
spl id: edb5015d-f063-5d1d-e053-2a95a90ab16d
spl set id: 59774c8a-deaf-53a6-e053-2991aa0a709f

Reported adverse events (FAERS/openFDA)#

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