FDA Label for Nite-timecold/flu Cherry Cold/flu Cherry
View Indications, Usage & Precautions
- DRUG FACTSACTIVE INGREDIENTS (IN EACH 30 ML DOSE CUP)
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- PREGNANT OR BREAST-FEEDING
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- NITE TIME CHERRY PRODUCT LABEL
Nite-timecold/flu Cherry Cold/flu Cherry Product Label
The following document was submitted to the FDA by the labeler of this product Salado Sales, 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.
Drug Factsactive Ingredients (In Each 30 Ml Dose Cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Keep Out Of Reach Of Children
Keep out of reach of children.
Uses
temporarily relieves cold/flu symptoms:
- sore throat
- minor aches and pain
- runny nose and sneezing
- cough due to minor sore throat and bronchial irritation
- headache
- fever
Warnings
Failure to follow these warnings could result in serious consequences
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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, 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 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 sleepy
Ask A Doctor Before Use If You Have
- a sodium restricted diet
- 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
- if you are taking the blood thinning drug warfarin
When Using This Product
- do not use more than directed
- 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
Stop Use And Ask A Doctor If
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts
These could be signs of a serious condition.
Pregnant Or Breast-Feeding
ask a health professional before use.
Overdose Warning
Taking more than the recommended dose can cause serious health problems. In case of 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.
Directions
- take only as recommended-see Overdose warnings
- Use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
- If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
adults & children 12 years and over 30 mL (2 TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
Other Information
- each 30 mL dose cup contains:
- sodium 45 mg
- store at room temperature
Inactive Ingredients
citric acid, FD and C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
Nite Time Cherry Product Label
Compare to VICKS® NYQUIL® active ingredients
CVP® CONSUMER VALUE PRODUCTS
Nite-Time COLD/FLU Medicine
Multi-Symptom CHERRY FLAVOR
Acetaminophen • Aches, Fever & Sore Throat
Dextromethorphan • Cough
Doxylamine Succinate • Sneezing, Runny nose
6 FL OZ (177 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil® LR-003
Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944
LR-003 Rev 02
Distributed by:
Salado Sales, Inc.
P.O. Box 6115 Temple, TX 76503
www.saladosales.com
LOT: EXP:
Peel Here DRUG FACTS CONTINUED ON BACK
CHERRY FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine
- Antihistamine
- Cough Suppressant
- Pain Reliever
- Fever Reducer
* Please review the disclaimer below.