FDA Label for Cold And Flu Night-time Multi Symptom Relief Cherry
View Indications, Usage & Precautions
- OTHER
- 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
- KEEP OUT OF REACH OF CHILDREN.
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
Cold And Flu Night-time Multi Symptom Relief Cherry Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, Llc. 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Otc - Purpose
Purpose
Acetaminophen Pain reliever/fever reducer
Dextromethorphan HBr Cough suppressant
Doxylamine Succinate Antihistamine
Indications & Usage
Uses temporarily relieves cold/flu symptoms: • sore throat
• headache • minor aches and pain • fever • runny nose and
sneezing • cough due to minor throat and bronchial irritation
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if you take
• more than 4,000 mg of Acetaminophen in 24 hours, which is the maximum daily amount
• 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
two 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. • to make a child sleepy
Otc - Ask Doctor
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.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use • if you are taking sedatives
or tranquilizers • if you are taking the blood thinning drug warfarin
Otc - When Using
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
Otc - Stop Use
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,
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.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Overdosage
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.
Dosage & Administration
Directions• take only as recommended-see Overdose
warning • Use dose cup or tablespoon ([BSP) • do not exceed
4 doses per 24 hours • If taking Night Time at night and Day
Time during the day, limit total to 4 doses per 24 hours.
adults & children 12 30 mL (2 TBSP)
years and over every 6 hours
children 4 to ask a doctor
under 12 years
children under 4 years do not use
Other Safety Information
Other information • each 30 mL dose cup
contains: sodium 45 mg • store at room temperature
Inactive Ingredient
Inactive ingredientscitric acid, FD&C Blue No.1,
FD&C Red No. 40, flavor, glycerin, polyethylene glycol,
propylene glycol, purified water, saccharin sodium sodium
benzoate, sodium citrate, sucrose
Otc - Questions
Questions? Call weekdays from 9:30 am to 4:30 pm EST.
1·877-798-5944.
Principal Display Panel
Premier Value®
COMPARE TO THE ACTIVE
INGREDIENTS IN
VICKS® NYQUIL®*
COLD & FLU
Night-time Multi-Symptom Relief
Acetaminophen...... Pain Reliever/Fever Reducer
Dextromethorphan HBr...... Cough Suppressant
Doxylamine Succinate....... Antihistamine
Cherry Flavor
8 FL OZ (237 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
Questions? Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by Proctor &
Gamble, owner of the registered trademark Vicks® NyQuil®.
DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087
If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund.
LR-025 REV 01
Product Label - Cold & Flu Night-time Multi Symptom Relief Cherry - 8 OZ Package
Product Label - Cold & Flu Night-time Multi Symptom Relief Cherry - 12 OZ Package
Premier Value® Cold & Flu Night-time Multi Symptom Relief Cherry
* Please review the disclaimer below.