FDA Label for Next Cold And Flu Nighttime
View Indications, Usage & Precautions
- DRUG FACTSACTIVE INGREDIENTS(IN EACH SOFTGEL)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- NEXT COLD & FLU NIGHTTIME PRODUCT LABEL
Next Cold And Flu Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Factsactive Ingredients(In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
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 cantains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maxium daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists 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
- 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 an MAOI drug. If you do not know if ask a doctor or pharmacist before taking this product.
- to make a child sleep
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
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
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 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
- a skin reaction occurs. 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.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
- take only as 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 - Children 4 to under 12 years: Ask a doctor
- When using Day Time ot Night Time products, carefully read each label to ensure correct dosing
Children under 4 years: Do not use
Other Information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredients
FD&C Blue # 1, D&C Yellow # 10, Gelatin, Glycerin, Polyethylene glycol, Povvidone, Propylene glycol, Purified water, Sorbital sorbitan solution, Titanium dioxide.
Questions?
Call 1-877-99-Genom (43666)
Weekdays from 8am to 6 pm
Next Cold & Flu Nighttime Product Label
NEXT
COLD & FLU
NIGHTTIME RELIEF
- Fever
- Sneezing
- Sore Throat
- Aches
- Runny Nose
- Cough
Acetaminophen/
Dextromethorphan HBr / Doxylamine succinate
Tamper evident: Do not use if blisters are torn or open
Distributed by:
Genomma Lab USA, Inc.
Houston, TX 77027
Made in India
BX-056
* Please review the disclaimer below.