DAYTIME NITETIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
American Sales Company
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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Active ingredients for NITETIME (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Active ingredients for DAYTIME (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose and sneezing (NITETIME only)
- nasal congestion (DAYTIME only)
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for these products
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using these products
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
- to make a child sleep (NITETIME only)
Ask a doctor before use if you have
- liver disease
- heart disease (Daytime only)
- thyroid disease (Daytime only)
- diabetes (Daytime only)
- high blood pressure (Daytime only)
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- glaucoma (NITETIME only)
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers (NITETIME only)
- taking the blood thinning drug warfarin
When using these products
- do not use more than directed
In addition, when using NITETIME:
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless (Daytime only)
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- new symptoms occur
- symptoms do not get better within 7 days or are accompanied by a fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition
Keep out of reach of children.
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms
Directions
- take only as directed – see overdose warning
- take Nitetime OR Daytime
Nitetime Softgels
- do not exceed 4 doses per 24 hours
| adults and children 12 years and over | swallow 2 softgels with water every 6 hrs |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Daytime Softgels
- do not exceed 4 doses per 24 hours
| adults and children 12 years and over | swallow 2 softgels with water every 4 hrs |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
- when using other Daytime or Nitetime products, carefully read each label to insure correct dosing
Inactive ingredients
Nitetime D&C Yellow #10, edible white printing ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol NF, povidone, propylene glycol, purified water, sorbitan, and sorbitol
Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white printing ink, FD&C Red #40*, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, and sorbitol
*may contain this ingredient
Principal Display Panel
Compare to active ingredients in Vicks® Nyquil® and Vicks® Dayquil®**
**These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® and Vicks® Dayquil®
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
Distributed by AMERICAN SALES COMPANY
4201 walden avenue
Lancaster, NY 14086
1-877-846-9949
| DAYTIME NITETIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit |
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| Labeler - American Sales Company (809183973) |