6183-combo Pack Cvs

6183-combo Pack Cvs
SPL v2
SPL
SPL Set ID 1532ee21-e114-ded7-e063-6294a90ab025
Route
ORAL
Published
Effective Date 2024-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Acetaminophen (1000 mg) Chlorpheniramine (4 mg)
Inactive Ingredients
Tribasic Calcium Phosphate Trisodium Citrate Dihydrate Starch, Corn Fd&c Blue No. 1 Maltodextrin Propylene Glycol Diacetyltartaric And Fatty Acid Esters Of Glycerol Yeast Sucrose Triacetin Silicon Dioxide Sucralose Acacia Acesulfame Potassium Anhydrous Citric Acid D&c Yellow No. 10 Soybean Lecithin Fd&c Red No. 40 Medium-chain Triglycerides Tartaric Acid

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-04-05 Until 2025-10-21

Description

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


Medication Information

Warnings and Precautions

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.

Description

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

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

Section 34088-5

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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

When using this product do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

Section 50569-3

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

Section 50570-1

• 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.

Section 51727-6

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.

Section 53413-1

Questions? 1-800-231-4670

Section 53414-9

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

Section 55105-1

Purposes



Pain reliever/fever reducer

Cough suppressant

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

Drug Facts

Active ingredients (in each packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Draft Label

Other Information

each packet contains: sodium 6 mg, potassium 10 mg

• Store in a dry place at 15° – 30°C (59° – 86°F).


Structured Label Content

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

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

• 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.

Section 51727-6 (51727-6)

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.

Section 53413-1 (53413-1)

Questions? 1-800-231-4670

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes



Pain reliever/fever reducer

Cough suppressant

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

Drug Facts

Active ingredients (in each packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Draft Label

Other Information (Other information)

each packet contains: sodium 6 mg, potassium 10 mg

• Store in a dry place at 15° – 30°C (59° – 86°F).


Advanced Ingredient Data


Raw Label Data

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