DAYTIME NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Drug Details [pdf]

Active ingredients for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg
Active ingredients for Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg
Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant
Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine
Uses
- temporarily relieves common cold and flu symptoms:
  - sore throat
  - headache
  - minor aches and pains
  - fever
  - cough due to minor throat and bronchial irritation
  - nasal congestion (Daytime only)
  - runny nose and sneezing (Nighttime only)
Warnings
Liver warning: These products contain 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 these products
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
- to make a child sleep (Nighttime only)
- 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.
Ask a doctor before use if you have
- liver disease
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nighttime only) chronic bronchitis
- glaucoma (Nighttime only)
- diabetes (Daytime only)
- heart disease (Daytime only)
- thyroid disease (Daytime only)
- high blood pressure (Daytime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product,

do not exceed recommended dosage.

In addition, when using Nighttime:
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur (Daytime only)
- pain, cough, and (for Daytime only) nasal congestion 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.

Overdose warning: Taking more than the recommended dose can cause liver damage. 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
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- swallow whole; do not crush, chew, or dissolve
Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours.

Nighttime: adults and children 12 years and over: take 2 softgels with water very 6 hours.
- children under 12 years: do not use
Other information
- store at room temperature 15°-30°C (59°-86°F)
- avoid excessive heat
Inactive ingredients

in Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol *may contain this ingredient

in Nighttime D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Vicks® NyQuil® and Vicks® DayQuil® LiquiCaps® active ingredients†

Non-Drowsy DAYTIME COLD & FLU RELIEF

Multi-Symptom
- Fever, aches & sore throat
- Cough
- Nasal congestion
ACETAMINOPHEN, Dextromethorphan HBr, Phenylephrine HCl

Alcohol free, Antihistamine free

DAYTIME SOFTGELS

Multi-Symptom NIGHTTIME COLD & FLU RELIEF
- Fever, aches & sore throat
- Cough
- Runny nose
ACETAMINOPHEN, Dextromethorphan HBr, Doxylamine Succinate

Alcohol free

NIGHTTIME SOFTGELS

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks®, DayQuil®, NyQuil® and LiquiCaps®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

www.cvs.com 1-800-shop-CVS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Product Label

CVS Daytime and Nighttime Cold Flu Relief Softgels

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-491

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 59779-491-48	1 in 1 CARTON; Type 0: Not a Combination Product	05/31/2013	12/31/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	2 BLISTER PACK	16
Part 2	4 BLISTER PACK	32

Part 1 of 2

NIGHTTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P30;94A;35A
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/31/2013	12/31/2020

Part 2 of 2

DAYTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P19;95A;36A
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/31/2013	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/31/2013	12/31/2020

Labeler - CVS Pharmacy (062312574)

Registrant - P & L Development, LLC (800014821)

DAYTIME NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Daytime Nighttime Cold Flu Relief by

Drug Labeling and Warnings

Drug Details [pdf]

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product,

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.