Label: HEALTHMART MUCUS RELIEF FM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 62011-0219-1 - Packager: Mckesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 8, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
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Warnings
Liver warning: This product contains acetaminophen. severe liver damage may occur if you take:
- more than 12 caplets in 24 hours, which is maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
- Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
- liver disease
- 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 that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin
When using this product
do not use more than directed
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.
- Directions
- Other information
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Inactive ingredients
Colloidal silicon dioxide, croscaramellose sodium, crospovidone, FD&C blue 1 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide. May contain methacrylic acid copolymer, sodium bicarbonate
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PDP
Health Mart
compare to Mucinex Fast-MaxTM Cold, Flu and Sore Throat active ingredients
for ages 12+
mucus relief FM
adult cold, flu and sore throat
acetaminophen.....pain reliever/Fever reducer
dextromethorphan HBr.....cough Suppressant
guaifenesin....expectorant
phenylephrine HCl.....nasal congestion
soothing relief for headache, fever, cough, nasal and chest congestion
thins and loosens mucus
20 Caplets
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INGREDIENTS AND APPEARANCE
HEALTHMART MUCUS RELIEF FM
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0219 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 68401960MK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain METHACRYLIC ACID (UNII: 1CS02G8656) May contain SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color blue Score no score Shape capsule Size 19mm Flavor Imprint Code G196 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0219-1 2 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/04/2013 Labeler - Mckesson (177667227)