Label: HEALTHMART MUCUS RELIEF FM- acetaminophen, guaifenesin, phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 62011-0217-1 - 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 9, 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
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Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- fever
- headache
- minor aches and pains
- sinus congestion and pressure
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
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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
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 red 40 aluminum lake, FD&C yellow 6 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 & sinus caplets active ingredients
for ages 12+
mucus relief FM
adult cold and sinus
acetaminophen.....pain reliever/Fever reducer
guaifenesin....expectorant
phenylephrine HCl.....nasal congestion
soothing relief for headache, fever, nasal and chest congestion
thins and loosens mucus
20 Caplets
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INGREDIENTS AND APPEARANCE
HEALTHMART MUCUS RELIEF FM
acetaminophen, guaifenesin, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0217 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 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 RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 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 orange Score no score Shape capsule Size 19mm Flavor Imprint Code G197 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0217-1 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)