NIGHTTIME COLD AND FLU RELIEF ALCOHOL FREE- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr liquid

Nighttime Cold and Flu Relief by

Drug Labeling and Warnings

Nighttime Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant

Uses

• temporarily relieves common cold and flu symptoms:
  • sore throat
  • minor aches and pains
  • headache
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• with other drugs containing acetaminophen
• more than 4,000 mg in 24 hours, which is the maximum daily amount
• 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.

Do not use

• 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 any of its ingredients
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

• liver disease
• glaucoma
• a sodium-restricted diet
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not exceed recommended dose
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery

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.

If pregnant or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed
  
• mL=milliliter; TBSP=tablespoon; FL OZ=fluid ounce
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• adults and children 12 years and over
  • take 30 mL (2 TBSP) in the dosing cup provided every 6 hours
  • do not exceed more than 4 doses in 24 hours
• children under 12 years: ask a doctor

Other information

• each 30 mL dose cup contains: sodium 13 mg
• store at 25ºC (77ºF); excursions permitted between 15º-30º C (59º-86ºF)
• use by expiration date on package

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, cherry flavor, FD&C red #40, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sucralose

Questions or comments?

1-800-426-9391

Principal Display Panel

♥︎CVS
Health™

Compare to the active ingredients in
Vicks® Alcohol Free NyQuil® Cold & Flu*

Cold/Flu

NDC: 69842-100-02

Alcohol Free

Nighttime
COLD & FLU RELIEF

ACETAMINOPHEN
Pain reliever/Fever reducer

CHLORPHENIRAMINE MALEATE
Antihistamine

DEXTROMETHORPHAN HBr
Cough suppressant

Relieves:
Aches, Fever, Cough,
Sore throat, Sneezing,
Runny nose

Cherry Flavor

12 FL OZ (355 mL)

*This product is not manufactured or distributed by Procter & Gamble, owner
of the registered trademark Vicks® Alcohol Free NyQuil® Cold & Flu.
50844              REV0416A00102

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V- 19849

✓CVS® Quality
Money Back Guarantee

CVS 44-001

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD AND FLU RELIEF  ALCOHOL FREE
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-100-02	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/05/2016

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(69842-100) , PACK(69842-100)