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- NDC Code(s): 63824-023-02, 63824-023-07, 63824-023-18, 63824-023-35, view more
63824-023-36, 63824-023-46, 63824-023-48, 63824-023-56
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- SPL UNCLASSIFIED SECTION
Drug Facts
- Active ingredient (in each extended-release bi-layer tablet)
Guaifenesin 1200 mg
- Purpose
Expectorant
- Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- Warnings
Do not use
- for children under 12 years of age
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)
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.
- Directions
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
- children under 12 years of age: do not use
- Other information
- store at 20-25°C (68-77°F)
- Inactive ingredients
carbomer homopolymer type B; FD&C blue no. 1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF
- Questions?
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
- SPL UNCLASSIFIED SECTION
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224Made in England
- PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton
NDC 63824-023-35
MAXIMUM STRENGTH
Mucinex®
1200 mg guaifenesin
extended-release bi-layer tabletsEXPECTORANT
12
HOUR®- 🗸
- Relieves Chest Congestion
- 🗸
- Thins and Loosens Mucus
- 🗸
- Immediate and Extended Release
14
EXTENDED-RELEASE
BI-LAYER TABLETS - INGREDIENTS AND APPEARANCE
MUCINEX MAXIMUM STRENGTH
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-023 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 1200mg Inactive Ingredients Ingredient Name Strength Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) hypromellose, unspecified (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) microcrystalline cellulose (UNII: OP1R32D61U) Product Characteristics Color WHITE (blue and white) Score no score Shape OVAL Size 22mm Flavor Imprint Code Mucinex;1200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-023-07 1 in 1 CARTON 06/11/2015 1 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63824-023-35 1 in 1 CARTON 06/26/2012 2 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63824-023-36 2 in 1 CARTON 06/26/2012 3 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:63824-023-48 4 in 1 CARTON 06/26/2012 4 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:63824-023-46 3 in 1 CARTON 06/26/2012 5 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:63824-023-18 2 in 1 CARTON 06/26/2012 06/15/2022 6 9 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:63824-023-02 1 in 1 CARTON 07/01/2021 7 1 in 1 POUCH; Type 0: Not a Combination Product 8 NDC:63824-023-56 4 in 1 CARTON 07/01/2021 8 14 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021282 06/26/2012 Labeler -RB Health (US) LLC(081049410)
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More Info on this Drug
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View Labeling Archives for this drug
MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release
Number of versions: 11
Published Date (What is this?) | Version | Files |
---|---|---|
Jun 20, 2022 | 13 (current) | download |
Apr 14, 2021 | 12 | download |
May 21, 2019 | 11 | download |
Aug 9, 2016 | 10 | download |
Dec 21, 2015 | 9 | download |
Jun 19, 2015 | 8 | download |
Oct 10, 2014 | 7 | download |
Jul 24, 2012 | 6 | download |
Jan 4, 2012 | 5 | download |
Jun 29, 2011 | 4 | download |
Dec 29, 2009 | 1 | download |
RxNorm
MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 310621 | guaiFENesin 1200 MG 12HR Extended Release Oral Tablet | PSN |
2 | 310621 | 12 HR guaifenesin 1200 MG Extended Release Oral Tablet | SCD |
3 | 310621 | guaifenesin 1200 MG 12 HR Extended Release Oral Tablet | SY |
4 | 891297 | Mucinex 1200 MG 12HR Extended Release Oral Tablet | PSN |
5 | 891297 | 12 HR guaifenesin 1200 MG Extended Release Oral Tablet [Mucinex] | SBD |
6 | 891297 | Mucinex 1200 MG 12 HR Extended Release Oral Tablet | SY |
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MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release
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NDC Codes
MUCINEX MAXIMUM STRENGTH- guaifenesin tablet, extended release
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 63824-023-02 |
2 | 63824-023-07 |
3 | 63824-023-18 |
4 | 63824-023-35 |
5 | 63824-023-36 |
6 | 63824-023-46 |
7 | 63824-023-48 |
8 | 63824-023-56 |