DailyMed - LEADER NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

NDC Code(s): 70000-0184-1, 70000-0184-2
Packager: Cardinal Health 110, LLC. dba Leader

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 27, 2025

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Active ingredients (in each 30 mL)
Acetaminophen 650 mg - Dextromethorphan HBr 30 mg - Doxylamine succinate 12.5 mg

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg
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Purpose
Pain reliever/fever reducer - Cough suppressant - Antihistamine

Pain reliever/fever reducer

Cough suppressant

Antihistamine
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Uses
temporarily relieves common cold/flu symptoms: • fever - • cough due to minor throat and bronchial irritation - • sore throat - • minor aches and pains - • runny nose and sneezing - • headache

temporarily relieves common cold/flu symptoms:

•

fever

•

cough due to minor throat and bronchial irritation

•

sore throat

•

minor aches and pains

•

runny nose and sneezing

•

headache

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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 ...

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

•

glaucoma

•

cough that occurs with too much phlegm (mucus)

•

a breathing problem such as emphysema or chronic bronchitis

•

trouble urinating due to an enlarged prostate gland

•

persistent or chronic cough as occurs with smoking, asthma, or emphysema

•

a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

•

taking sedatives or tranquilizers

•

taking the blood thinning drug warfarin

When using this product

•

excitability may occur, especially in children

•

marked drowsiness may occur

•

be careful when driving a motor vehicle or operating machinery

•

alcohol, sedatives, and tranquilizers may increase drowsiness

•

avoid alcoholic drinks

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 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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Directions
• take only as directed – see Overdose warning - • use dose cup - • do not exceed 4 doses per 24 hrs - adults & children 12 yrs & over - 30 mL every 6 hrs - children 4 to under 12 yrs - ask a ...

•

take only as directed – see Overdose warning

•

use dose cup

•

do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

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Other information
• each 30 mL contains: sodium 38 mg - • store at 20-25°C (68-77°F)

•

each 30 mL contains: sodium 38 mg

•

store at 20-25°C (68-77°F)

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Inactive ingredients
alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium ...

alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
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Questions or comments?
1-800-719-9260

1-800-719-9260
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Package/Label Principal Display Panel
LEADER™ Nighttime Cold & Flu - Acetaminophen - Dextromethorphan HBr - Doxylamine Succinate - Pain Reliever/Fever Reducer - Cough Suppressant - Antihistamine - Original Flavor - Relief of: Aches, Fever ...

LEADER™

Nighttime Cold & Flu

Acetaminophen

Dextromethorphan HBr

Doxylamine Succinate

Pain Reliever/Fever Reducer

Cough Suppressant

Antihistamine

Original Flavor

Relief of:

Aches, Fever, Cough,

Sore Throat, Sneezing

Runny Nose

COMPARE TO VICKS® NYQUIL® COLD & FLU active ingredients

ALCOHOL 10%

100% Money Back Guarantee

12 FL OZ (355 mL)

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INGREDIENTS AND APPEARANCE

Product Information

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Published Date (What is this?)	Version	Files
Mar 31, 2025	7 (current)	download
Nov 21, 2024	6	download
Oct 28, 2024	5	download
Jul 14, 2023	4	download
Jun 18, 2021	3	download
Jan 4, 2019	2	download
Nov 17, 2016	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN
2	1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD
3	1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY
4	1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY
5	1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY

Label: LEADER NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

adults & children 12 yrs & over	30 mL every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

	NDC
1	70000-0184-1
2	70000-0184-2

Label: LEADER NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

LEADER NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

Number of versions: 7

LEADER NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

LEADER NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

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LEADER NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.