NIGHTTIME COLD AND FLU by We Care Distributor Inc.
Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: We Care Distributor Inc.
NDC Code: 70005-005
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.
|Active Ingredient (in each softgel)||Purpose|
|Acetaminophen 325 mg||Pain reliever/fever reducer|
|Dextromethorphan HBr 15 mg||
Doxylamine succinate 6.25 mg
Temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- minor aches and pains
- runny nose and sneezing
- sore throat
This product contains acetaminophen. The maximum daily dose of this product is 8 softgels (2,600 mg acetaminophen) in 24 hours. 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
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly
- 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 monomine 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.
- to make a child sleepy
- if you have ever had an allergic reaction to this product or any of its ingredients
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- taking sedative or tranquilizers
- taking the blood thinning drug warfarin
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- may cause marked drowsiness
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
take only as directed - see Liver warning
do not exceed 8 softgels per 24 hours
adults and children 12 years and over: 2 softgels with water every 6 hours
children 4 to under 12 years: ask a doctor
children under 4 years: do not use
when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
store at 20º-25ºC (68º-77ºF)
- read all product information before using. Keep this box for important information
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, purified water, sorbitol special, sorbitol solution, titanium dioxide
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
|NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr and doxylamine succinate 325 mg, 15 mg and 6.25 mg capsule, liquid filled
|Labeler - We Care Distributor Inc. (079832998)|
|Softech Pharma Pvt. Ltd||677111277||manufacture(70005-005)|
Medically reviewed on Mar 1, 2018