Otc - Purpose
Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant
Guaifenesin Dm Syrup
FDA Label NDC 0121-0638
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Guaifenesin Dm (NDC 0121-0638). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, description, uses, otc - do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
| Each 5 mL (1 teaspoonful) contains: | |
| Guaifenesin | 100 mg |
| Dextromethorphan Hydrobromide | 10 mg |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Otc - Do Not Use
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 You Have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- you are hypersensitive to any of the ingredients.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Manufactured By
Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com
R11/16
Principal Display Panel - 5 Ml Unit Dose Cup Label
Delivers 5 mL
NDC 0121-0638-05
GUAIFENESIN SYRUP
and DEXTROMETHORPHAN
100 mg/10 mg per 5 mL
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F06380500
5 mL Unit Dose Cup Label (Guaifenesin Dm 01)
Principal Display Panel - 10 Ml Unit Dose Cup Label
Delivers 10 mL
NDC 0121-1276-10
GUAIFENESIN SYRUP
and DEXTROMETHORPHAN
200 mg/20 mg per 10 mL
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
A06381001
10 mL Unit Dose Cup Label (Guaifenesin Dm 02)
Principal Display Panel - 118 Ml Bottle Label
NDC 0121-0638-04
NSN 6505-01-318-1565
Quality®
Value
Guaifenesin-DM
100 mg/10 mg per 5 mL
EXPECTORANT/COUGH SUPPRESSANT
Compare to the
active ingredients in
*Robitussin
®-DM
CONTROLS COUGHS
LOOSENS AND RELIEVES
CHEST CONGESTION
4 fl oz (118 mL)
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
DRUG FACTS
Active Ingredient (in each 5 mL teaspoonful) Purpose
Guaifenesin 100 mg...................................................Expectorant
Dextromethorphan Hydrobromide 10 mg......Cough Suppressant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions
to make coughs more productive - temporarily relieves cough due to minor throat and bronchial
irritation as may occur with a cold - cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking,
asthma, chronic bronchitis, or emphysema - do not take more than 6 doses in any 24-hour period
- store at 20°-25°C (68°-77°F)
- alcohol-free
- packaged with tamper evident seal around cap
- sodium content 4 mg/5 mL
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 you have
Stop use and ask a doctor if cough lasts more
than 7 days, comes back, or is accompanies by fever, rash or
persistent headache. These could be signs of a serious
condition.
If pregnant or breast-feeding, ask a health professional before
use.
Keep out of reach of children. In case or overdose, get
medical help or contact a Poison Control Center right away.
Directions
| age | dose |
| adults and children
12 years and over | 2 teaspoonfuls
every 4 hours |
| children 6 years to
under 12 years | 1 teaspoonful
every 4 hours |
| children 2 years to
under 6 years | 1/2 teaspoonful
every 4 hours |
| under 2 years | ask a doctor |
Other Information
Inactive ingredients: citric acid, FD&C Red No. 40, flavoring, glycerin,
menthol, purified water, sodium benzoate, sodium citrate, sodium
saccharin, and sucrose.
*Robitussin® is a registered trademark of Wyeth Consumer Healthcare.
118 mL Bottle Label (Guaifenesin Dm 03)
Principal Display Panel - 237 Ml Bottle Label
NDC 0121-0638-08
Quality®
Value
Guaifenesin-DM
100 mg/10 mg per 5 mL
EXPECTORANT/COUGH SUPPRESSANT
Compare to the
active ingredients in
*Robitussin
®-DM
CONTROLS COUGHS
LOOSENS AND RELIEVES
CHEST CONGESTION
8 fl oz (237 mL)
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
DRUG FACTS
Active Ingredient (in each 5 mL teaspoonful) Purpose
Guaifenesin 100 mg...................................................Expectorant
Dextromethorphan Hydrobromide 10 mg......Cough Suppressant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions
to make coughs more productive - temporarily relieves cough due to minor throat and bronchial
irritation as may occur with a cold - cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking,
asthma, chronic bronchitis, or emphysema - do not take more than 6 doses in any
24-hour period - store at 20°-25°C (68°-77°F)
- alcohol-free
- packaged with tamper evident seal around cap
- sodium content 4 mg/5 mL
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 you have
Stop use and ask a doctor if cough lasts more
than 7 days, comes back, or is accompanies by fever, rash or
persistent headache. These could be signs of a serious
condition.
If pregnant or breast-feeding, ask a health professional before
use.
Keep out of reach of children. In case or overdose, get
medical help or contact a Poison Control Center right away.
Directions
| age | dose |
| adults and children
12 years and over | 2 teaspoonfuls
every 4 hours |
| children 6 years to
under 12 years | 1 teaspoonful
every 4 hours |
| children 2 years to
under 6 years | 1/2 teaspoonful
every 4 hours |
| under 2 years | ask a doctor |
Other Information
Inactive ingredients: citric acid, FD&C Red
No. 40, flavoring, glycerin, menthol, purified
water, sodium benzoate, sodium citrate, sodium
saccharin, and sucrose.
*Robitussin® is a registered trademark of Wyeth Consumer Healthcare.
R11/04
237 mL Bottle Label (Guaifenesin Dm 04)
Principal Display Panel - 473 Ml Bottle Label
NDC 0121-0638-16
Quality®
Value
Guaifenesin-DM
100 mg/10 mg per 5 mL
EXPECTORANT/COUGH SUPPRESSANT
Compare to the
active ingredients in
*Robitussin
®-DM
CONTROLS COUGHS
LOOSENS AND RELIEVES
CHEST CONGESTION
16 fl oz (473 mL)
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
DRUG FACTS
Active Ingredient (in each 5 mL teaspoonful) Purpose
Guaifenesin 100 mg...................................................Expectorant
Dextromethorphan Hydrobromide 10 mg......Cough Suppressant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions
to make coughs more productive - temporarily relieves cough due to minor throat and bronchial
irritation as may occur with a cold - cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking,
asthma, chronic bronchitis, or emphysema - do not take more than 6 doses in any
24-hour period - store at 20°-25°C (68°-77°F)
- alcohol-free
- packaged with tamper evident seal around cap
- sodium content 4 mg/5 mL
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 you have
Stop use and ask a doctor if cough lasts more
than 7 days, comes back, or is accompanies by fever, rash or
persistent headache. These could be signs of a serious
condition.
If pregnant or breast-feeding, ask a health professional before
use.
Keep out of reach of children. In case or overdose, get
medical help or contact a Poison Control Center right away.
Directions
| age | dose |
| adults and children
12 years and over | 2 teaspoonfuls
every 4 hours |
| children 6 years to
under 12 years | 1 teaspoonful
every 4 hours |
| children 2 years to
under 6 years | 1/2 teaspoonful
every 4 hours |
| under 2 years | ask a doctor |
Other Information
Inactive ingredients: citric acid, FD&C Red
No. 40, flavoring, glycerin, menthol, purified
water, sodium benzoate, sodium citrate, sodium
saccharin, and sucrose.
*Robitussin® is a registered trademark of Wyeth Consumer Healthcare.
R08/04
473 mL Bottle Label (Guaifenesin Dm 05)
* Please review the disclaimer below.
