COLD MULTI-SYMPTOM- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl 
Wal-Mart Stores Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Equate 44-470C473

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 ingredients (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

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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 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

Other information

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?

1-888-287-1915

Principal Display Panel

NDC 49035-931-08

equate™                             Compare to Tylenol® COLD MAX Day & Tylenol® Cold Multi-Symptom Night Active Ingredients*

Non-Drowsy

DayTime

Cold Multi-Symptom

• Acetaminophen,
  Dextromethorphan HBr
  Phenylephrine HCl

• Pain reliever, fever reducer,
  cough suppressant, nasal decongestant

• Fever, headache, sore throat,
  nasal congestion, cough

 Pseudoephedrine Free

12
CAPLETS
                  Actual Size


NightTime

Cold Multi-Symptom
• Acetaminophen,

  Chlorpheniramine maleate,
  Dextromethorphan HBr
  Phenylephrine HCl

• Pain reliever, fever reducer, antihistamine,
  cough suppressant, nasal decongestant

• Fever, headache, sore throat,
  runny nose, nasal congestion, cough

 Pseudoephedrine Free

12
CAPLETS 
                Actual Size

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

Do not take the Daytime and Nighttime caplets at the same time

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
*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.

50844    REV0821J47047308

Equate 44-470C473

Equate 44-470C473

COLD MULTI-SYMPTOM 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-931
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-931-081 in 1 CARTON; Type 0: Not a Combination Product07/21/2005
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
DAYTIME COLD MULTI SYMPTOM 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code 44;470
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2005
Part 2 of 2
NIGHTTIME COLD MULTI SYMPTOM 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize17mm
FlavorMINTImprint Code 44;473
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/21/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/21/2005
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(49035-931) , pack(49035-931)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(49035-931)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(49035-931)

Revised: 3/2022
Document Id: de7b2a49-3154-4e85-835b-67369361161a
Set id: 077fac1a-0ec5-40d9-8861-a281b48f650a
Version: 11
Effective Time: 20220321
 
Wal-Mart Stores Inc