OTC Medication Information: Guaifenesin and Pseudoephedrine HCl

GUAIFENESIN AND PSEUDOEPHEDRINE HCL- guaifenesin and pseudoephedrine tablet, extended release
Ohm Laboratories, Inc.

Active ingredients (in each extended-release bi-layer tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

Active ingredients (in each extended-release bi-layer tablet)

Purposes

Guaifenesin 1200 mg

Expectorant

Pseudoephedrine HCl 120 mg

Nasal Decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome 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 contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

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 a 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.

If pregnant or breast-feeding , 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
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
children under 12 years of age: do not use

Other Information

Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer, NF; FD&C Yellow #6; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Questions?

call 1-800-406-7984

You may also report side effects to this phone number.

Keep the carton. It contains important information.

See end panel for expiration date.

Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

0219

Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg Extended-Release Bi-Layer Tablets — Carton Label

NDC 51660-058-18

Compare To
the active ingredients of
Mucinex® D

ohm®

Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg
Extended-Release Bi-Layer Tablets

Expectorant & Nasal Decongestant

12 Hour

Clears Nasal/Sinus Congestion
Thins and Loosens Mucus
Immediate and Extended Release

18 Extended-Release Bi-Layer Tablets

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

600 mg/60 mg Carton Label
(click image for full-size original)

Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg Extended-Release Bi-Layer Tablets — Carton Label

NDC 51660-057-12

Compare To
the active ingredients of
Mucinex® D

ohm®

Maximum Strength
Guaifenesin 1200 mg & Pseudoephedrine HCl 120 mg
Extended-Release Bi-Layer Tablets

Expectorant & Nasal Decongestant

12 Hour

Clears Nasal/Sinus Congestion
Thins and Loosens Mucus
Immediate and Extended Release

12 Extended-Release Bi-Layer Tablets

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

1200 mg/120 mg Carton Label
(click image for full-size original)
GUAIFENESIN AND PSEUDOEPHEDRINE HCL
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-058
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 600 mg
PSEUDOEPHEDRINE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE 60 mg
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (10000 MPA.S)
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE (white to off-white) , ORANGE (orange to light orange) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 058
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-058-18 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (51660-058-18)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212542 04/01/2021
GUAIFENESIN AND PSEUDOEPHEDRINE HCL
guaifenesin and pseudoephedrine hcl tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 1200 mg
PSEUDOEPHEDRINE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE 120 mg
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (10000 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE (white to off-white) , ORANGE (orange to light orange) Score no score
Shape OVAL Size 22mm
Flavor Imprint Code 057
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-057-12 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (51660-057-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212542 04/01/2021
Labeler — Ohm Laboratories, Inc. (184769029)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories, Inc. 184769029 MANUFACTURE (51660-058), MANUFACTURE (51660-057)

Revised: 04/2021 Ohm Laboratories, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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