GILTUSS COUGH AND COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Gil Pharmaceutical Corp
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Antitussive Expectorant Nasal Decongestant Uses Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.
Authorization status:
OTC monograph final
Authorization number:
58552-331-20

GILTUSS COUGH AND COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

Gil Pharmaceutical Corp

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.

----------

Giltuss Cough & Cold Tablets

Drug Facts

Active Ingredients (in each tablet)

Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

Purposes

Antitussive

Expectorant

Nasal Decongestant

Uses

Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other

upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial

secretions, drain bronchial tubes, make coughs more productive, clear stuffy nose, clear nasal

passageways, and shrinks swollen membranes.

Warnings

Do not use more than the recommended dosage

or 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 are uncertain whether your prescription drug contains an MAOI, ask

a health professional.

Ask a doctor before use if you have:

heart disease

excessive phlegm (mucus)

high blood pressure

diabetes

thyroid disease

difficulty in urination due to enlargement of the prostate gland

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if:

nervousness, dizziness, or sleeplessness occurs

symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)

cough and congestion do not improve within 7 days or tend to recur

These could be signs of a serious condition.

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

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison

Control Center immediately.

Directions

Adults and Children 12 years and over: Take 1 tablet every 6 to 8 hours. Do not take more than 4

tablets in a 24 hour period.

Children 6 to 12 years of age: Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a

24-hour period.

Children under 6 years of age: Consult a physician.

Other information

Store at room temperature, USP

Do not use if blister seal is broken

Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate,

Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone,

Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

Questions or Comments? Call 787-848-9114, Mon.-Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor

for medical advice in the event of side effects.

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

MAXIMUM STRENGTH

Giltuss ®

COUGH & COLD

20 TABLETS

SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

RELIEVES

COUGH AND COLD

CHEST CONGESTION

LOOSENS PHLEGM AND MUCUS

STUFFY NOSE

NASAL CONGESTION

SINUS PRESSURE

GILTUSS COUGH AND COLD

dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 552-331

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

38 8 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

28 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MAGNESIUM SILICATE (UNII: 9 B9 6 9 1B2N9 )

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ9 7GEP)

Gil Pharmaceutical Corp

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MINERAL O IL (UNII: T5L8 T28 FGP)

PO VIDO NE K3 0 (UNII: U725QWY32X)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

white

S core

2 pieces

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

GILGIL;30 330 3

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 552-331-20

2 in 1 CARTON

10 /11/20 18

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

10 /11/20 18

Labeler -

Gil Pharmaceutical Corp (176826592)

Revised: 4/2019

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