ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE- acetaminophen, dextromethorphan hbr, chlorpheniramine maleate 
CVS Pharmacy, Inc

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6183-Combo Pack CVS

Day Time Powder

Drug Facts

Active ingredients (in each packet)
Acetaminophen 1000 mg
Dextromethorphan HBr 30 mg

Purposes

Pain reliever/fever reducer
Cough suppressant

Uses

• temporarily relieves these symptoms due to a common cold or flu:
• minor aches and pains • minor sore throat pain • headache
• cough due to minor throat and bronchial irritation
• temporarily reduces fever

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.

• in a child under 12 years of age

• if you are allergic to acetaminophen
• 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

• a breathing problem such as emphysema or chronic bronchitis

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin

When using this product do not use more than directed.

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 a rash or headache that lasts
These could be signs of a serious condition.

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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 use more than directed
• take every 6 hours, while symptoms persist
• Do not take more than 4 packets in 24 hours unless directed by a doctor
• dissolve contents of one packet into 8 oz. hot water, sip while hot. Consume entire drink within 10 - 15 minutes.

• if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.

AgeDose
adults and children 12 years
of age and over
one packet
children under 12 years of agedo not use

Other information

each packet contains: sodium 6 mg, potassium 10 mg
• Store in a dry place at 15° – 30°C (59° – 86°F).

acacia, acesulfame potassium, anhydrous citric acid, corn starch, D&C yellow #10, diacetyl tartaric and fatty acid esters of glycerol, FD&C blue #1, FD&C red #40, maltodextrin, medium chain triglycerides, natural flavor, propylene glycol, silicon dioxide, soy lecithin,
sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate, yeast.

Nighttime Powder

Drug Facts

Active ingredients (in each packet)
Acetaminophen 1000 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg

Purposes
Pain reliever/Fever reducer
Antihistamine
Cough suppressant

Uses

• temporarily relieves these symptoms due to a common cold or flu:
• minor aches and pains • minor sore throat pain
• headache • runny nose • cough due to minor throat and bronchial irritation
• temporarily reduces fever

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

• in a child under 12 years of age

• if you are allergic to acetaminophen

• 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

• glaucoma

• trouble urinating due to an enlarged prostate gland

• a breathing problem such as emphysema or chronic bronchitis

• cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product
do not exceed recommended dosage

• avoid alcoholic drinks

• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness

• be careful when driving a motor vehicle or operating machinery

• excitability may occur, especially in children

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 a rash or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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 use more than directed
• take every 6 hours, while symptoms persist
• Do not take more than 4 packets in 24 hours unless directed by a doctor

• dissolve contents of one packet into 8 oz. hot water, sip while hot. Consume entire drink within 10 - 15 minutes.
• if using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.

AgeDose
adults and children 12 years
of age and over
one packet
children under 12 years of agedo not use

Other information

• each packet contains: sodium 6 mg, potassium 10 mg
• Store in a dry place at 15° – 30°C (59° – 86°F).

acacia, acesulfame potassium, anhydrous citric acid, corn starch, D&C yellow #10, diacetyl tartaric and fatty acid esters of glycerol, FD&C red #40, maltodextrin, medium chain triglycerides, natural flavor, propylene glycol, silicon dioxide, soy lecithin, sucralose, sucrose, tartaric acid, triacetin, tribasic calcium phosphate, trisodium citrate dihydrate, yeast.

Questions? 1-800-231-4670

Draft Label

CVS Label

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE 
acetaminophen, dextromethorphan hbr, chlorpheniramine maleate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-609
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-609-071 in 1 CARTON; Type 1: Convenience Kit of Co-Package04/05/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 6   in 12 
Part 21 PACKET 6   in 12 
Part 1 of 2
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr powder
Product Information
Item Code (Source)NDC:51316-605
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
YEAST (UNII: 3NY3SM6B8U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
TARTARIC ACID (UNII: W4888I119H)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
ACACIA (UNII: 5C5403N26O)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRIACETIN (UNII: XHX3C3X673)  
SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
Product Characteristics
Coloryellow (Light Yellow) Score    
ShapeSize
FlavorHONEY (Honey Lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-605-056 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/05/2024
Part 2 of 2
ACETAMINOPHEN, DEXTROMETHORPHAN HBR 
acetaminophen, dextromethorphan hbr powder
Product Information
Item Code (Source)NDC:51316-604
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
Inactive Ingredients
Ingredient NameStrength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
YEAST (UNII: 3NY3SM6B8U)  
SUCROSE (UNII: C151H8M554)  
TRIACETIN (UNII: XHX3C3X673)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TARTARIC ACID (UNII: W4888I119H)  
Product Characteristics
Coloryellow (Light yellow) Score    
ShapeSize
FlavorHONEY (Honey Lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-604-056 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/05/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/05/2024
Labeler - CVS Pharmacy, Inc (062312574)

Revised: 4/2024
Document Id: 1532ee21-e115-ded7-e063-6294a90ab025
Set id: 1532ee21-e114-ded7-e063-6294a90ab025
Version: 1
Effective Time: 20240403
 
CVS Pharmacy, Inc