FDA Label for Cold And Flu Night Time Multi-symptom Relief Original

Other

DRUG FACTS

Otc - Active Ingredient

Active ingredients (in each 30 mL dose cup)
Acetaminophen                650 mg
Dextromethorphan HBr      30mg
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 askin 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.

Otc - 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 (TBSP)
• do not exceed 4 doses per 24 hours

adults and children 12              30 mL (2 TBSP)
years and over                         every 6 hours

children 4 to                             ask a doctor
under 12 years                     

children under 4years              do not use

• If taking Night Time at night and Day Time during the day,
limit total to 4 doses per 24 hours.

Other Safety Information

Other information • each 30 mL dose cup contains:
sodium 45 mg • store at room temperature

Inactive Ingredient

Inactive ingredients citric acid, D&C yellow # 10, FD&C
Green No.3, FD&C Yellow No.6, 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®*

Original Flavor

COLD & FLU
Night-time Multi-Symptom Relief

Acetaminophen...... Pain Reliever/Fever Reducer
Dextromethorphan Hbr...... Cough Suppressant
Doxylamine Succinate........Antihistamine

Non-drowsy

8 FL OZ (237 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

Questions? Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by Proctor &
Gamble, owner of the registered trademark Vicks® NyQuil®.
If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund.

DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087

LR-023

REV-01

Product label - 8 OZ Package

Product label - 12 OZ Package

                                                  Premier^® Value Cold & Flu Night-time Multi-Symptom Relief Original