SEVERE COLD DAY COLD and FLU NIGHT by RETAIL BUSINESS SERVICES , LLC. 1177-CAR-2020-0819
SEVERE COLD DAY COLD and FLU NIGHT by
Drug Labeling and Warnings
SEVERE COLD DAY COLD and FLU NIGHT by is a Otc medication manufactured, distributed, or labeled by RETAIL BUSINESS SERVICES , LLC.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
SEVERE COLD DAY COLD AND FLU NIGHT- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride
RETAIL BUSINESS SERVICES , LLC.
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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1177-CAR-2020-0819
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- cough (DAY TIME SEVERE COLD ONLY)
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing (NIGHT TIME COLD & FLU ONLY)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME SEVERE COLD ONLY)
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets 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.
- with any other product containing diphenhydramine, even one used on skin (NIGHT TIME COLD & FLU 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 this product.
- for children under 12 years of age
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
- glaucoma (NIGHT TIME COLD & FLU ONLY)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME COLD & FLU ONLY)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME SEVERE COLD ONLY)
- cough that occurs with too much phlegm (mucus) (DAY TIME SEVERE COLD ONLY)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (NIGHT TIME COLD & FLU ONLY)
When using this product
- do not use more than directed
- excitability may occur, especially in children (NIGHT TIME COLD & FLU ONLY)
- marked drowsiness may occur (NIGHT TIME COLD & FLU ONLY)
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME COLD & FLU ONLY)
- avoid alcoholic drinks (NIGHT TIME COLD & FLU ONLY)
- be careful when driving a motor vehicle or operating machinery (NIGHT TIME COLD & FLU 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.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take Day Time and Night Time caplets at the same time
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Other information
- store between 20-25°C (68-77°F) in a dry place
- keep outer package for complete product information
Inactive ingredients
DAY TIME SEVERE COLD
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL
COMBINATION PACK
NDC: 72476-177-02
CARE ONE®
For Ages 12+
Maximum Strength
SEVERE COLD DAY
Pain Reliever/Fever Reducer - Acetaminophen
Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin
Nasal Decongestant - Phenylephrine HCl
FOR RELIEF OF:
Aches, Fever + Sore Throat & Cough
Nasal + Chest Congestion
Thins and Loosens Mucus
Actual Size
20 DAY CAPLETS
COLD & FLU NIGHT
Pain Reliever/Fever Reducer - Acetaminophen
Antihistamine - Diphenhydramine HCl
Nasal Decongestant - Phenylephrine HCl
FOR RELIEF OF:
Aches, Fever + Sore Throat
Nasal Congestion
Runny Nose + Sneezing
Actual Size
10 NIGHT CAPLETS
| SEVERE COLD DAY COLD AND FLU NIGHT
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit |
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| Labeler - RETAIL BUSINESS SERVICES , LLC. (967989935) |