Chloresin

Manufacturer
Affasco Inc. | ULTRAtab laboratories, Inc. | ULTRA SEAL CORPORATION
Effective date
2019-09-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:00:33

Label at a glance#

ProductChloresin
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (In Each Tablet)

Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Pain reliever/fever reducer, Cough suppressant, Expectorant, Nasal decongestant

INDICATIONS & USAGE SECTION

Uses: For temporary relief of:

• cough • sore throat • minor aches • pain

• headaches • nasal congestion • fever

• helps loosen phlegm (mucus), thin bronchial secretions to make coughs more productive

WARNINGS SECTION

Warnings:

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, if you take with other drugs containing acetaminophen (prescription or nonprescription), or if you have 3 or more alcoholic drinks every day while using this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that occurs with too much phlegm (mucus), chronic cough that lasts such as occurs with smoking, asthma, or emphysema or chronic bronchitis.

OTC - STOP USE SECTION

Stop use and ask a doctor if: you get nervous, dizzy or sleepless, cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signsof a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions: Do not use more than directed.

Adults and children: (12 years and older) Take 2 tablets with water every 6-8 hours as needed. Do not take more than 8 tablets in 24 hours, or as directed by doctor.

Children: (under 12 years) Do use unless directed by a doctor.

INACTIVE INGREDIENT SECTION

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AffascoChloresin12-16AffascoChloresin12-16

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN4
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD4
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51532-0107-22023-01-30C16284748780-1f386c649-ace9-0266-e053-dadaa90a7c1a77a5f0d0-18cf-4618-85b7-90c86a1f2e23

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51532-0107-2Chloresin2 in 1 PACKETTABLET24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51532-0107CHLORESIN (ACETAMINOPHEN, DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) TABLET [AFFASCO INC.]4Legacy NDC, 1 package rows20190923_77a5f0d0-18cf-4618-85b7-90c86a1f2e23.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51532-010751532-0107-2

Ingredients#

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

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

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
b85b5e6c-6918-494d-972c-6ac09a9ba50477a5f0d0-18cf-4618-85b7-90c86a1f2e232019-09-21WarningsExact identifier
spl id: b85b5e6c-6918-494d-972c-6ac09a9ba504
spl set id: 77a5f0d0-18cf-4618-85b7-90c86a1f2e23

Reported adverse events (FAERS/openFDA)#

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