DAYTIME COLD, NIGHTTIME COLD MULTI-SYMPTOM- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit

Daytime Cold, Nighttime Cold by

Drug Labeling and Warnings

Daytime Cold, Nighttime Cold by is a Otc medication manufactured, distributed, or labeled by United Natural Foods, Inc. dba UNFI, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients(in each caplet) (Daytime Cold Multi-Symptom)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Active ingredient (in each caplet) (Nighttime Cold Multi-Symptom)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • cough
  • sore throat
  • headache
  • nasal congestion
  • minor aches and pains
  • sinus congestion and pressure
  • sneezing and runny nose (Nighttime only)
• helps clear nasal passages
• relieves cough to help you sleep (Nighttime only)
• promotes nasal and sinus drainage (Daytime only)
• temporarily reduces fever

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
• 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 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• liver disease
• diabetes
• thyroid disease
• heart disease
• glaucoma (Nighttime only)
• cough that occurs with too much phlegm (mucus)
• high blood pressure 
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis (Nighttime 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
• excitability may occur, especially in children (Nighttime only)
• marked drowsiness may occur (Nighttime only)
• avoid alcoholic beverages (Nighttime only)
• use caution when driving a motor vehicle or operating machinery (Nighttime only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• new symptoms occur
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• 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.

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Directions

• do not take more than directed 
• adults and children 12 years and over
  
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 hours
• children under 12 years: ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number
  
  

Inactive ingredients (Daytime only)

corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Inactive ingredients (Nighttime only)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-877-932-7948

Principal Display Panel

EQUALINE®

NDC: 41163-529-08

compare to Tylenol® COLD MAX Day & Tylenol® Cold Multi-Symptom Night active ingredients*

• multi-symptom daytime cold acetaminophen (pain reliever/fever reducer)dextromethorphan HBr(cough suppressant)phenylephrine HCl(nasal decongestant) non-drowsy relieves: fever/headache/sore throat coughing nasal congestion PSEUDOEPHEDRINE FREE:

  multi-symptom;

  nighttime ; cold

  acetaminophen ; (pain reliever/fever reducer); chlorpheniramine maleate; (antihistamine); dextromethorphan HBr; (cough suppressant); phenylephrine HCl; (nasal decongestant)

  relieves:; fever/headache/sore throat; runny nose; coughing ; nasal congestion

  PSEUDOEPHEDRINE FREE

Actual Size

24 caplets with cool blast flavor (12 daytime + 12 nighttime)

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

DOES NOT CONTAIN GLUTEN
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® COLD MAX Day & Tylenol® Cold Multi-Symptom Night.

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRiE, MN 55344 USA
877-932-7948
www.supervaluprivatebrands.com

44-470C473

INGREDIENTS AND APPEARANCE

DAYTIME COLD, NIGHTTIME COLD  MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-529

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-529-08	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	07/21/2005

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	12

Part 1 of 2

DAYTIME COLD  MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor	MINT	Imprint Code	44;470
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/15/2005

Part 2 of 2

NIGHTTIME COLD  MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	17mm
Flavor	MINT	Imprint Code	44;473
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/21/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/21/2005

Labeler - SUPERVALU INC. (006961411)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(41163-529)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(41163-529)