FDA Label for Night Time Multi-symptom Cold And Flu Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABELING: DISCOUNT DRUG MART NIGHT TIME MULTI-SYMPTOM COLD & FLU RELIEF
Night Time Multi-symptom Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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.
Otc - Active Ingredient
Drug Facts
Active Ingredients (In each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Otc - Purpose
Purpose
Acetaminophen Pain reliever/Fever reducer
Dextromethorphan HBr Cough suppressant
Doxylamine succinate Antihistamine
Indications & Usage
UsesTemporarily relieves common cold and flu symptoms:
• cough due to minor throat and bronchial irritation
• sore throat
• minor aches and pain
• fever
• runny nose and sneezing
Warnings
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 8 Liquid Caps in 24 hours, which is the maximum daily
amount for this product • with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
• skin reddening • blisters • rash.
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 is followed by fever, headache, rash,
nausea or vomiting, consult a doctor promptly.
Otc - Do Not Use
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
Otc - Ask Doctor
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 an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
Otc - When Using
When using this product, do not use more than directed.
• 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
Otc - Stop Use
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.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - 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.
Dosage & Administration
Directions
• take only as directed (see Warning)
• do not exceed 4 doses per 24 hours
Adults and Children 12 yrs & over | 2 softgels with water every 6 hours |
Children 4 to under 12 yrs | ask a doctor |
Children under 4 yrs | do not use |
• when using other Daytime or Nighttime products,
carefully read each label to ensure correct dosing
Other Safety Information
Other information
• store at room temperature 20-2S·C (68-77"F)
• avoid excessive heat
Inactive Ingredient
Inactive ingredientsD&C Yellow # 10, FD&C Blue # 1,
Gelatin, glycerin, Polyethylene glycol, Povidone, Propylene Glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide.
Otc - Questions
Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Package Labeling: Discount Drug Mart Night Time Multi-Symptom Cold & Flu Relief
DISCOUNT NDC-53943-603-03
drug mart
FOOD MARKET
Cold &
Flu Relief
MULTI-SYMPTOM
NIGHT TIME
*Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu LiquiCaps™
24 Softgels
DISTRIBUTED BY:
DRUG MART - FOOD FAIR
211 COMMERCE DRIVE
MEDINA, OH 44256
www.discount-drugmart.com
This product is not manufactured or distributed by Procter
& Gamble, owner of the registered trademark Vicks®
DayOuilTM LiquiCapsTM
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE
WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON
FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256
* Please review the disclaimer below.