NDC | 68210-0111-1 |
Set ID | 0d811f94-16b1-4ba8-aeea-6f947b69ba24 |
Category | HUMAN OTC DRUG LABEL |
Packager | SPIRIT PHARMACEUTICALS LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 liquid gels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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 nonprescription). 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
- diabetes
- high blood pressure
- thyroid disease
- 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)
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 headache that lasts. These could be signs of a serious condition.
-
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 liquid gels in any 24-hour period
- adults and children 12 years of age and older: take 2 liquid gels every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions or Comments?
-
PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton
COMPARE TO ACTIVE INGREDIENTS IN
MUCINEX® FAST-MAX® COLD, FLU & SORE THROAT*ASSURED™
MAXIMUM STRENGTH
Mucus Relief
-
Acetaminophen 325 mg
- -
- Pain Reliever / Fever Reducer
- Dextromethorphan HBr 10 mg - Cough Suppressant
- Guaifenesin 200 mg - Expectorant
- Phenylephrine HCl 5 mg - Nasal Decongestant
Thins & Loosens Mucus,
Nasal Congestion,
Coughing, Fever & Headache
Non-DrowsyActual Size
AGES 12+
10 softgels -
Acetaminophen 325 mg
-
INGREDIENTS AND APPEARANCE
ASSURED MAXIMUM STRENGTH MUCUS RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0111 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 FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE (LIGHT) Score no score Shape OVAL (oblong) Size 21mm Flavor Imprint Code 341 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0111-1 1 in 1 CARTON 08/12/2016 1 10 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 OTC MONOGRAPH FINAL part341 08/12/2016 Labeler - SPIRIT PHARMACEUTICALS LLC (179621011) Establishment Name Address ID/FEI Business Operations MEDGEL PRIVATE LTD 872779008 MANUFACTURE(68210-0111)