FDA Label for Nighttime Cold And Flu Relief

View Indications, Usage & Precautions

ACTIVE INGREDIENTS (IN EACH SOFTGELS)
PURPOSE
USES
WARNINGS
OTHER
KEEP OUT OF REACH OF CHILDREN
DIRECTION
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
DISTRIBUTED BY:
PRINCIPAL DISPLAY PANEL-24 COUNT
PRINCIPAL DISPLAY PANEL-96 COUNT

Nighttime Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Bi-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.

Active Ingredients (In Each Softgels)

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 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

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, 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 drug containing acetaminophen (prescription or non-prescription).
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.
if you have ever had an allergic reaction to this product or any of its ingredients

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.

These could be signs of a serious condition.

Other

If pregnant or breast-feeding,ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-122) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Direction

take only as directed
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
children under 4 years	do not use

Other Information

store at room temperature.
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

D&C yellow# 10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution

Questions?

call toll-free 1-844-912-4012

Distributed By:

BI-MART

Eugene, OR 97402

Principal Display Panel-24 Count

NDC 37835-522-24

Compare to the active ingredients in Vicks ^®NyQuil ^®Cold & Flu LiquiCaps ^®*

NIGHTTIME COLD AND FLU RELIEF

Acetaminophen,

Doxylamine Succinate,

Dextromethorphan HBr

24 SoftGels

*This product is not manufactured or distributed by the owner of the registered trademark Vicks ^®NyQuil ^®Cold & Flu LiquiCaps ^®*

label - label 24

Principal Display Panel-96 Count

NDC 37835-522-96