DailyMed - BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coated

NDC Code(s): 80267-023-62
Packager: Live Betr LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated February 5, 2025

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Active ingredients (in each caplet)
Acetaminophen 325 mg - Dextromethorphan HBr 10 mg - Doxylamine succinate 6.25 mg - Phenylephrine HCl 5 mg

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg
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Purpose
Pain reliever/fever reducer - Cough suppressant - Antihistamine - Nasal decongestant

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant
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Uses
• temporarily relieves common cold/flu symptoms: • nasal congestion - • sinus congestion and pressure - • cough due to minor throat and bronchial irritation - • cough to help you sleep - • minor aches ...

•

temporarily relieves common cold/flu symptoms:

•

nasal congestion

•

sinus congestion and pressure

•

cough due to minor throat and bronchial irritation

•

cough to help you sleep

•

minor aches and pains

•

headache

•

fever

•

sore throat

•

runny nose and sneezing

•

reduces swelling of nasal passages

•

temporarily restores freer breathing through the nose

•

promotes nasal and/or sinus drainage

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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

•

heart disease

•

high blood pressure

•

thyroid disease

•

diabetes

•

glaucoma

•

cough that occurs with too much phlegm (mucus)

•

a breathing problem such as emphysema or chronic bronchitis

•

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

•

trouble urinating due to an enlarged prostate gland

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 use more than directed

•

excitability may occur, especially in children

•

marked drowsiness may occur

•

avoid alcoholic drinks

•

be careful when driving a motor vehicle or operating machinery

•

alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

•

you get nervous, dizzy or sleepless

•

pain, nasal congestion, 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.

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Directions
• take only as directed – see overdose warning - • do not exceed 8 caplets per 24 hrs - adults & children 12 yrs & over - 2 caplets with water every 4 hrs - children 4 to under 12 yrs - ask a ...

•

take only as directed – see overdose warning

•

do not exceed 8 caplets per 24 hrs

adults & children 12 yrs & over

2 caplets with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

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Inactive ingredients
crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose ...

crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
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Questions or comments?
1-800-719-9260

1-800-719-9260
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Package/Label Principal Display Panel
Same Relief. BETR Mission. BETR remedies™ Nighttime - cold & flu relief - Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr, Caplets - Pain Reliever, Fever Reducer, Cough ...

Same Relief.

BETR Mission.

BETR remedies™

Nighttime

cold & flu relief

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr, Caplets

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant

Relief Of: Minor Aches & Pains; Fever; Nasal Congestion & Sinus Pressure; Sneezing, Runny Nose; Cough

Compare to Vicks® NyQuil® Severe VapoCOOL™ active ingredients.

….If you’re comparing.

24 CAPLETS

Actual Size

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INGREDIENTS AND APPEARANCE

Product Information

BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80267-023
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L72V
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80267-023-62	6 in 1 CARTON	12/08/2022	05/31/2025
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	12/08/2022	05/31/2025

Labeler - Live Betr LLC (117423281)

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	RxCUI	RxNorm NAME	RxTTY
1	1546881	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet	PSN
2	1546881	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD
3	1546881	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY

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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	2 caplets with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

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

BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenyle...BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coatedview full title

Number of versions: 1

BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenyle...BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coatedview full title

BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenyle...BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coatedview full title

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BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenyle...BETR REMEDIES NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coatedview full title

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