ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE kit

Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate by

Drug Labeling and Warnings

Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

• Age: Dose
• adults and children 12 years of age and over: one packet
• children under 12 years of age: do 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.

• Age: Dose
• adults and children 12 years of age and over: one packet
• children under 12 years of age: do 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

Questions? 1-800-231-4670

Draft Label

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE 
acetaminophen, dextromethorphan hbr, chlorpheniramine maleate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-609

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-609-07	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	04/05/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	6   in 12
Part 2	1 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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	1000 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor	HONEY (Honey Lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-605-05	6 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/05/2024

Part 2 of 2

ACETAMINOPHEN, DEXTROMETHORPHAN HBR 
acetaminophen, dextromethorphan hbr powder

Product Information
Item Code (Source)	NDC: 51316-604
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	1000 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (Light yellow)	Score
Shape		Size
Flavor	HONEY (Honey Lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-604-05	6 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/05/2024

Labeler - CVS Pharmacy, Inc (062312574)