DAY SEVERE COLD NIGHT COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, doxylamine succinate kit
day severe cold night cold and flu by
Drug Labeling and Warnings
day severe cold night cold and flu by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each liquid gel) – DAY Severe Cold
- Purposes – DAY Severe Cold
- Active ingredients (in each liquid gel) – NIGHT Cold & Flu
- Purposes – NIGHT Cold & Flu
-
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- minor aches and pains
- headache
- nasal congestion
- sore throat
- runny nose and sneezing (NIGHT only)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
- controls cough to help you get to sleep (NIGHT only)
- temporarily reduces fever
-
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 these products
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 these products.
- if you have ever had an allergic reaction to these products or any of their ingredients
-
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
- glaucoma (NIGHT only)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
- 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
-
When using these products
- do not use more than directed
- excitability may occur, especially in children (NIGHT only)
- marked drowsiness may occur (NIGHT only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
- avoid alcoholic drinks (NIGHT only)
- be careful when driving a motor vehicle or operating machinery (NIGHT only)
-
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.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients (DAY only)
- Inactive ingredients (NIGHT only)
- Questions or comments?
-
Package/Label Principal Display Panel
COMBO PACK
Compare to the active ingredients of Mucinex® Fast-Max® Day Severe Cold & Mucinex® Fast-Max® Night Cold & Flu
fast dissolving liquid gels
MAXIMUM STRENGTH
daytime
day
severe cold
acetaminophen
dextromethorphan HBr
guaifenesin
phenylephrine HCl
pain reliever/fever reducer
cough suppressant
expectorant
nasal decongestant
relieves aches, fever & sore throat
controls cough
relieves nasal & chest congestion
thins & loosens mucus
ACTUAL SIZE
16 LIQUID GELS
(liquid filled capsules)
24 TOTAL for ages 12+
MAXIMUM STRENGTH
nighttime
night
cold & flu
acetaminophen
dextromethorphan HBr
doxylamine succinate
phenylephrine
pain reliever/fever reducer
cough suppressant
antihistamine
nasal decongestant
relieves aches, fever & sore throat
controls cough
relieves nasal congestion
relieves runny nose & sneezing
ACTUAL SIZE
24 TOTAL
for ages 12+
8 LIQUID GELS
(liquid filled capsules)
-
INGREDIENTS AND APPEARANCE
DAY SEVERE COLD NIGHT COLD AND FLU
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 11822-0717 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 11822-0717-0 1 in 1 KIT; Type 0: Not a Combination Product 06/28/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 Part 2 8 Part 1 of 2 DAY SEVERE COLD
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filledProduct Information 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 (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 25mm Flavor Imprint Code 7G0 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 Part 2 of 2 NIGHT COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filledProduct Information 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 20mm Flavor Imprint Code 345 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/28/2017 Labeler - Rite Aid Corporation (014578892)
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