FDA Label for Nighttime Cold And Flu
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 LABEL.PRINCIPAL DISPLAY PANEL
Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Kroger. 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
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Indications & Usage
Uses temporarily relieves common cold/flu symptoms:
-cough due to minor throat and bronchial irritation
-sore throat
-headache
-minor aches and pains
-fever
-runny nose and sneezing
Warnings
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.
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.
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 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
-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 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.
Dosage & Administration
Directions
- take only as directed
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over-30 mL every 6 hrs
children 4 to under 12 yrs-ask a doctor
children under 4 yrs-do not use
Other Safety Information
Other information
- each 30 mL contains: sodium 52 mg
- store at no greater than 25°C and do not refrigerate
Inactive Ingredient
Inactive ingredients alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
Otc - Questions
Questions or comments? Call 1-800-632-6900
* Please review the disclaimer below.