NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled
A&Z Pharmaceutical, Inc.
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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Nighttime Cold and Flu Relief
USES
temporarily relieves common cold and flu symptoms:
- Cough due to minor throat and bronchial irritation
- Sore throat
- headache
- minor aches and pains
- fever, runny nose and sneezing
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 product 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- Liver disease
- glaucoma
- 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
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drink
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever get worse or last 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
Keep Out of Reach of Children
Overdose warning: In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs of symptoms
DIRECTIONS
- do not take more than directed (see Warnings)
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over:
- take 2 softgels with water every 6 hours
- Ask a doctor
- Do not use
INACTIVE INGREDIENTS
FD&C Green #3, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol. May also contain FD&C Blue #1, D&C Yellow #10, titanium dioxide.
PRINCIPAL DISPLAY PANEL
*Compare to active ingredients in Vicks® Nyquil® Cold & Flu LiquiCaps
*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Nyquil® Cold & Flu LiquiCaps
Acetaminophen/Dextromethorphan/Doxylamine
- Aches
- Fever
- Sore Throat
- Sneezing
- Runny nose
- Cough
| NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled |
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| Labeler - A&Z Pharmaceutical, Inc. (926820705) |
| Registrant - A&Z Pharmaceutical, Inc. (926820705) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| A&Z Pharmaceutical, Inc. | 926820705 | manufacture(62211-340) | |