Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
027630078
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
BI-MART
BI-MART
118917568
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NIGHTTIME COLD AND FLU
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
temporarily relieves common cold/flu symptoms:
• sore throat
• minor aches and pains
• runny nose and sneezing
• headache
• fever
• cough due to minor throat and bronchial irritation.
DOSAGE & ADMINISTRATION SECTION
Directions
• take only as directed (see overdose warning)
• measure only with dosing cup provided and keep dosage cup with product
• mL=mililiter
• do not exceed 4 doses per 24 hours
|
Age |
Dose |
|
adults and children 12 years and over |
30 mL every 6 hours |
|
children under 12 years |
do not use |
WARNINGS SECTION
Warnings
**Liver warning:**This product contains acetaminophen. Severe liver damage may occur if:
• adults and children over 12 years of age take more than 4 doses (30 mL each)
in 24 hours, which is the maximum daily amount for this product
• taken with other drugs containing acetaminophen
• adult has 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, lasts for mroe than 2 days, is accompanied or followed by fever, heacache, rash, nausea, or vomiting, consult a doctor promptly.
OVERDOSAGE SECTION
Overdose warning:
Taking mroe than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
OTC - PURPOSE SECTION
Purpose
Pain Reliever/Fever Reducer
Cough Suppressant
Antihistamine
OTC - ASK DOCTOR SECTION
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 occur with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to an enlarged prostate gland.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
OTC - DO NOT USE SECTION
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.
• if you have ever had an allergic reaction to this product or anay of its ingredients
OTC - STOP USE SECTION
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 - WHEN USING SECTION
When using this product
• do not use more than directed (see overdose warning)
• avoid alcoholic drinks
• excitability may occur, especially in children
• marked drowsiness may occur
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness.
OTC - QUESTIONS SECTION
Questions or comments?
1-844-912-4012
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
ask a health professional before use.
OTHER SAFETY INFORMATION
Other Information
•**Each 30 mL dose cup contains:**sodium 10 mg
• store at room temperature 15-30°C (59-86°F) and do not refrigerate
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.