up and up mucus relief dm DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN TARGET CORPORATION FDA Approved Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep Warnings Do not use • for children under 12 years of age • 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 • 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 • cough lasts more than 7 days, comes back, or occurs with 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)
FunFoxMeds box
Route
ORAL
Applications
ANDA207602

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended-release tablet) Dextromethorphan HBr 30 mg Guaifenesin 600 mg
Inactive Ingredients
Inactive ingredients carbomer homopolymer type B copovidone D&C yellow #10 aluminum lake hypromellose magnesium hydroxide magnesium stearate microcrystalline cellulose silicon dioxide
Strengths
30 mg 600 mg
Treats Conditions
Uses Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive Temporarily Relieves Cough Due To Minor Throat And Bronchial Irritation As May Occur With The Common Cold Or Inhaled Irritants The Intensity Of Coughing The Impulse To Cough To Help You Get To Sleep Warnings Do Not Use For Children Under 12 Years Of Age 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 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 Cough Lasts More Than 7 Days Comes Back Or Occurs With 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
Pill Appearance
Shape: oval Color: yellow Imprint: L219;600

Identifiers & Packaging

Container Type BOX
UNII
9D2RTI9KYH 495W7451VQ
Packaging

Principal Display Panel Compare to active ingredients in Mucinex ® DM Mucus Relief DM Guaifenesin 600 mg Dextromethorphan Hydrobromide 30 mg Extended-Release Tablets Expectorant / Cough Suppressant • Controls cough • Thins and loosens mucus 12 Hour up&up ™ Actual Size 40 Extended-Release Tablets 40 EXTENDED-RELEASE TABLETS up&up-mucus-relief-dm-carton-image.jpg

Package Descriptions
  • Principal Display Panel Compare to active ingredients in Mucinex ® DM Mucus Relief DM Guaifenesin 600 mg Dextromethorphan Hydrobromide 30 mg Extended-Release Tablets Expectorant / Cough Suppressant • Controls cough • Thins and loosens mucus 12 Hour up&up ™ Actual Size 40 Extended-Release Tablets 40 EXTENDED-RELEASE TABLETS up&up-mucus-relief-dm-carton-image.jpg

Overview

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep Warnings Do not use • for children under 12 years of age • 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 • 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 • cough lasts more than 7 days, comes back, or occurs with 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)

Indications & Usage

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep Warnings Do not use • for children under 12 years of age • 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 • 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 • cough lasts more than 7 days, comes back, or occurs with 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)

Dosage & Administration

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 • adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours • children under 12 years of age: do not use

Warnings & Precautions
Warnings
Purpose

Purposes Cough suppressant Expectorant

Do Not Use

Do not use • for children under 12 years of age • 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.

When Using

When using this product • do not use more than directed

Stop Use & Ask a Doctor

Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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. (1-800-222-1222)

Storage & Handling

Other information • each tablet contains: magnesium 15 mg • do not use if printed foil under cap is broken or missing. • store between 20-25°C (68-77°F)

Questions

Questions or comments? 1-888-547-7400


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