CHLORESIN- acetaminophen, dextromethorphan, guaifenesin, phenylephrine tablet

Chloresin by

Drug Labeling and Warnings

Chloresin by is a Otc medication manufactured, distributed, or labeled by Affasco Inc., ULTRAtab laboratories, Inc., ULTRA SEAL CORPORATION, ULTRAtab LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (In Each Tablet)

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

PURPOSE

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

INDICATIONS & USAGE

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

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.

ASK DOCTOR

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.

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

OVERDOSAGE

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

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

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

CHLORESIN 
acetaminophen, dextromethorphan, guaifenesin, phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51532-0107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51532-0107-2	2 in 1 PACKET; Type 0: Not a Combination Product	10/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/25/2016

Labeler - Affasco Inc. (609982723)

Registrant - ULTRAtab laboratories, Inc. (151051757)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(51532-0107)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab LABORATORIES, INC.		151051757	manufacture(51532-0107)