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NDC 55111-0798-09 Guaifenesin and Pseudoephedrine HCL 600; 60 mg/1; mg/1 Details

Guaifenesin and Pseudoephedrine HCL 600; 60 mg/1; mg/1

Guaifenesin and Pseudoephedrine HCL is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Reddys Laboratories Limited. The primary component is GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 55111-0798-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Related Packages: 55111-0798-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	55111-0798
Product ID	55111-798_029cd2ef-2247-abda-d74e-4b589a7dae62
Associated GPIs	43996202307435
GCN Sequence Number	012073
GCN Sequence Number Description	guaifenesin/pseudoephedrne HCl TAB ER 12H 600MG-60MG ORAL
HIC3	B4W
HIC3 Description	DECONGESTANT-EXPECTORANT COMBINATIONS
GCN	54980
HICL Sequence Number	000270
HICL Sequence Number Description	GUAIFENESIN/PSEUDOEPHEDRINE HCL
Brand/Generic	Generic
Proprietary Name	Guaifenesin and Pseudoephedrine HCL
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin and Pseudoephedrine HCL
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	600; 60
Active Ingredient Units	mg/1; mg/1
Substance Name	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Dr. Reddys Laboratories Limited
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208369
Listing Certified Through	2024-12-31

Package

Package Images

NDC 55111-0798-09 (55111079809)

Pricing Information	N/A
NDC Package Code	55111-798-09
Billing NDC	55111079809
Package	1 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2017-12-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 845a2dcc-9069-3141-ae13-f2063f36d130 Details

Active ingredient(s)

Guaifenesin USP, 600 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant

Guaifenesin USP, 1200 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant

Purpose

Expectorant and Nasal Decongestant

Use(s)

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive

■ temporarily relieves nasal congestion due to:

■ common cold

■ hay fever

■ upper respiratory allergies

■ temporarily restores freer breathing through the nose

■ promotes nasal and/or sinus drainage

■ temporarily relieves sinus congestion and pressure

Warnings

Do not use

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 if

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

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

■ cough accompanied by too much phlegm (mucus)

When using this product

■ do not use more than directed

Stop use and ask doctor if

■ you get nervous, dizzy, or sleepless

■ symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

■ do not crush, chew, or break tablet

■ take with a full glass of water

■ this product can be administered without regard for timing of meals

■ children under 12 years of age: do not use

For 600 mg/60 mg

■ adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours

For 1200 mg/120 mg

■ adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours

Other information

■ tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.

Storage

■ store between 20°-25°C (68°-77°F)

Inactive ingredients

FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

Questions

call 1-888-375-3784

You may also report side effect to this phone number.

Keep the carton.

It contains important information.

See end panel for expiration date.

Manufactured by:

Dr. Reddy’s Laboratories Limited

Srikakulam – 532 409 INDIA

Principal Display Panel

Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg:

PRINCIPAL DISPLAY PANEL

Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg: 18s (1x18s)

PRINCIPAL DISPLAY PANEL

Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg: 36s (2x18s)

PRINCIPAL DISPLAY PANEL

Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg:

PRINCIPAL DISPLAY PANEL

Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg: 24s (4x6s)

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND PSEUDOEPHEDRINE HCL

guaifenesin and pseudoephedrine hcl tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-798
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	600 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	60 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	RDY;798
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-798-09	1 in 1 CARTON	12/29/2017
1		9 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:55111-798-18	2 in 1 CARTON	12/29/2017
2		9 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:55111-798-36	4 in 1 CARTON	12/29/2017
3		9 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:55111-798-35	1 in 1 CARTON	01/23/2020
4		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:55111-798-41	2 in 1 CARTON	03/11/2020
5		18 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208369	12/29/2017

GUAIFENESIN AND PSEUDOEPHEDRINE HCL

guaifenesin and pseudoephedrine hcl tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-799
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	1200 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	120 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	RDY;799
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-799-12	1 in 1 CARTON	12/29/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:55111-799-24	2 in 1 CARTON	12/29/2017
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:55111-799-36	3 in 1 CARTON	12/29/2017
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:55111-799-04	4 in 1 CARTON	12/29/2017
4	NDC:55111-799-06	6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208369	12/29/2017

Labeler - Dr. Reddys Laboratories Limited (650562841)

Name	Address	ID/FEI	Business Operations
Establishment
Dr. Reddys Laboratories Limited (SEZ UNIT)		860037244	manufacture(55111-798, 55111-799) , analysis(55111-798, 55111-799)

Revised: 3/2020

Document Id: 029cd2ef-2247-abda-d74e-4b589a7dae62

Set id: 845a2dcc-9069-3141-ae13-f2063f36d130

Version: 7

Effective Time: 20200311

Search by Drug Name or NDC

NDC 55111-0798-09 Guaifenesin and Pseudoephedrine HCL 600; 60 mg/1; mg/1 Details

Guaifenesin and Pseudoephedrine HCL 600; 60 mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 55111-0798-09 (55111079809)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 845a2dcc-9069-3141-ae13-f2063f36d130 Details

Active ingredient(s)

Purpose

Use(s)

Warnings

Do not use

Ask a doctor before use if

When using this product

Stop use and ask doctor if

Pregnancy/Breastfeeding

Keep out of reach of children

Directions

Other information

Storage

Inactive ingredients

Questions

Principal Display Panel

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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