NDC | 0363-0840-16 |
Set ID | e1f8cf03-d4fc-42b3-aada-efc3ffd8e1ba |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreens |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each softgel)
- Purpose
-
Uses
DAYTIME
- temporarily relieves
- cough due to inhaled irritants
- nasal congestion
- headache
- sinus congestion and pressure
- minor aches and pains
- promoted nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves
-
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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
DAYTIME
- liver disease
- diabetes
- high blood pressure
- heart disease
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a 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
- 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 coukld be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief active ingredients††
Severe Sinus Congestion
ACETAMINOPHEN 325 mg / PAIN RELIEVER
DEXTROMETHORPHAN HBr 10 mg / COUGH SUPPRESSANT
GUAIFENESIN 200 mg / EXPECTORANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTION
MAXIMUM STRENGTH
- Relieves sinus congestion & headsache
- Thins & loosens mucus
- Controls cough
- Ages 12 & older
- Alcohol free
SOFTGELS**
(**LIQUID-FILLED CAPSULES)
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
- Product Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF SEVERE SINUS CONGESTION
acetaminophen dextromethorphan hbr guaifenesin phenylephrine hci capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0840 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) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape OVAL Size 20mm Flavor Imprint Code 341;12A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0840-16 16 in 1 CARTON 12/31/2018 04/30/2023 1 1 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 12/31/2018 04/30/2023 Labeler - Walgreens (008965063)