FDA Label for Day And Night Multi Symptom Cold And Flu Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS/COMMENTS
- PRINCIPAL DISPLAY PANEL
Day And Night Multi Symptom Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Intrivo Diagnostics 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.
Active Ingredient(S)
Active Ingredients (in each softgel)
Nighttime only
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg
Active Ingredients (in each softgel)
Daytime only
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Purpose
Nighttime only
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Daytime only
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Use(S)
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
- nasal congestion (Daytime only)
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right
away.
Sore throat warning: If sore throat is severe, lasts for more
than 2 days, occurs with or 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 drugs. 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 (Nighttime only)
Ask A Doctor Before Use If
- liver disease
- 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 an enlarged prostate gland
- glaucoma (Nighttime only)
- heart disease
- thyroid disease
- diabetes high blood sugar (Daytime only)
Ask A Doctor Or Pharmacist Before Use If
you are taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When Using This Product
When using this product
- do not use more than directed
- 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 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.
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults) (Daytime only)
These could be signs of a serious condition.
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of Reach Of Children
Taking more than directed can cause serious health problems. 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.
Directions
Directions (Nighttime only)
- take only as directed
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: 2 softgels with water every 4 hours
Children 4 to under 12 years: do not use
Children under 4 years: ask a doctor - take only as directed
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: 2 softgels with water every 6 hours
Children 4 to under 12 years: do not use
Children under 4 years: ask a doctor
Directions (Daytime only)
Other Information
- store at room temperature 20-25 °C (68-77° F)
- do not use if blister unit is torn or open
Inactive Ingredients
Inactive ingredients (Nighttime only)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol sorbitan
solution, white edible ink
Inactive ingredients (Daytime only)
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone,
propylene glycol, purified water, sorbitol sorbitan solution, white
edible ink
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
Day and Night Multi symptom
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