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NDC 51660-0057-12 Guaifenesin and Pseudoephedrine HCl 1200; 120 mg/1; mg/1 Details
Guaifenesin and Pseudoephedrine HCl 1200; 120 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 Ohm Laboratories, Inc.. The primary component is GUAIFENESIN; PSEUDOEPHEDRINE.
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: 51660-0057-12Last 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: 51660-0057-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 51660-0057 |
|---|---|
| Product ID | 51660-057_efb49ad2-ac54-4918-9c5a-7228a6dfa21c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | 1200; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | GUAIFENESIN; PSEUDOEPHEDRINE |
| Labeler Name | Ohm Laboratories, Inc. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212542 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51660-0057-12 (51660005712)
| NDC Package Code | 51660-057-12 |
|---|---|
| Billing NDC | 51660005712 |
| Package | 1 BLISTER PACK in 1 CARTON (51660-057-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2021-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL efb49ad2-ac54-4918-9c5a-7228a6dfa21c Details
SPL UNCLASSIFIED SECTION
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
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- 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.
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
Inactive Ingredients
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.
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.
INGREDIENTS AND APPEARANCE
| GUAIFENESIN AND PSEUDOEPHEDRINE HCL
guaifenesin and pseudoephedrine hcl tablet, extended release |
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| GUAIFENESIN AND PSEUDOEPHEDRINE HCL
guaifenesin and pseudoephedrine hcl tablet, extended release |
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| Labeler - Ohm Laboratories, Inc. (184769029) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories, Inc. | 184769029 | MANUFACTURE(51660-058, 51660-057) | |