NDC | 37808-317-25 |
Set ID | d2b016ee-5329-45bf-9d71-d626204169cf |
Category | HUMAN OTC DRUG LABEL |
Packager | H E B |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients
Drug Facts
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Active ingredients (in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg - Purpose
- Keep out of reach of children
Keep out of reach of children.
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In case of overdose, get medical help or contact a Poison Control Center right away. - 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.
- for children under 12 years of age
- Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
- When using this product
- Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- symptoms do not get better within 7 days or are accompanied by a fever
- cough comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
- If pregnant or breast feeding,
- Directions
Age - Adults and children 12 years and older Dose - 20 mL every 4 hours
Age - Children under 12 years of age Dose - Do not usetake only as recommended
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use dosage cup
mL = milliliter
do not take more than 6 doses in any 24-hour period - Other information
- each 20 mL contains: sodium 10 mg
- dosage cup provided
- store between 15-30° C (59-86° F)
- do not refrigerate
- Inactive ingredients
anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum
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- Uses
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
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temporarily relieves these symptoms occurring with a cold:
cough due to minor throat and bronchial irritation
nasal congestion - Product Label
Compare to MUCINEX® FAST-MAX™, Severe Congestion and Cough active ingredients*
NDC 37808-317-25
H-E-B®
MAX SEVERE CONGESTION AND COUGHMaximum Strength
Dextromethorophan HBr
(Cough Suppressant)
Guaifenesin
(Expectorant)
Phenylephrine HCL
(Nasal Decongestant)
Controls Cough
Thins and Loosens Mucus
Relieves Nasal and Chest Congestion
6 FL OZ (177mL)
Adults
For Ages 12 and Over
*This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Severe Congestion and Cough.MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TEXAS, 782044
GUARANTEE
We believe the high quality of the H-E-B product makes an outstanding value. We hope you'll agree. If not, we'll cheerfully refund your money. Thanks for shopping with us.
Peel Corner to Read Complete Drug Facts and Information
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
LF-001 1208
Lot:
Exp - INGREDIENTS AND APPEARANCE
H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-317 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-317-25 177 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/14/2012 Labeler - H E B (007924756) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(37808-317)