DAYTIME NIGHTIME SEVERE COLD- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride
CVS Pharmacy
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.
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CVS Pharmacy, Inc. Daytime Nighttime Severe Cold Drug Facts
Active ingredients (in each caplet) DAY TIME COLD & FLU
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Active ingredients (in each caplet) NIGHT TIME COLD & FLU
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Purposes - Night Time
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Uses
- •
- temporarily relieves these common cold and flu symptoms:
- •
- cough
- •
- minor aches and pains
- •
- headache
- •
- nasal congestion
- •
- sore throat
- •
- sinus congestion and pressure
- •
- runny nose (NIGHT TIME only)
- •
- sneezing (NIGHT TIME only)
- •
- itching of the nose or throat (NIGHT TIME only)
- •
- itchy, watery eyes due to hay fever (NIGHT TIME only)
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
- •
- controls cough to help you get to sleep
- •
- 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.
- •
- with any other product containing diphenhydramine, even one used on skin (NIGHT TIME only)
- •
- 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 TIME only)
- •
- a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME 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
- •
- taking the blood thinning drug warfarin
- •
- taking sedatives or tranquilizers (NIGHT TIME only)
When using these products
- •
- do not use more than directed
- •
- excitability may occur, especially in children (NIGHT TIME only)
- •
- marked drowsiness may occur (NIGHT TIME only)
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
- •
- avoid alcoholic drinks (NIGHT TIME only)
- •
- be careful when driving a motor vehicle or operating machinery (NIGHT TIME 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.
Directions
- •
- do not take more than directed (see Overdose warning)
- •
- do not take more than 10 caplets in any 24-hour period
- •
- adults and children 12 years of age and over: take 2 caplets every 4 hours
- •
- children under 12 years of age: do not use
Other information
- •
- each caplet contains: sodium 4 mg (DAY TIME COLD & FLU only)
- •
- store at 20-25°C (68-77°F)
Inactive ingredients (DAY TIME COLD & FLU)
croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Inactive ingredients (NIGHT TIME COLD & FLU)
crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Package/Label Principal Display Panel
Compare to the active ingredients in Mucinex® Fast-Max® Day Time & Night Time
MAXIMUM STRENGTH
Daytime
Severe Cold
Acetaminophen
Pain reliever, Fever reducer
Dextromethorphan HBr
Cough suppressant
Guaifenesin – Expectorant
Phenylephrine HCl
Nasal decongestant
MULTI-SYMPTOM
Controls cough
Thins & loosens mucus
Relieves nasal & chest congestion
Relieves aches, fever & sore throat
FOR AGES 12+
Actual Size
MAXIMUM STRENGTH
Nighttime
Severe Cold
Acetaminophen
Pain reliever, Fever reducer
Diphenhydramine HCl
Antihistamine, Cough Suppressant
Phenylephrine HCl
Nasal decongestant
MULTI-SYMPTOM
Controls cough
Relieves runny nose & sneezing
Relieves nasal congestion
Relieves aches, fever & sore throat
FOR AGES 12+
Actual Size
20 DAYTIME CAPLETS & 10 NIGHTTIME CAPLETS
TOTAL 30 CAPLETS
| DAYTIME NIGHTIME SEVERE COLD
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride kit |
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| Labeler - CVS Pharmacy (062312574) |