SEVERE CONGESTION AND COUGH, COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

Severe Congestion and Cough, Cold and Flu by

Drug Labeling and Warnings

Severe Congestion and Cough, Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Severe Congestion & Cough

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • nasal congestion due to a cold

Warnings

Do not use

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

• difficulty in urination due to enlargement of the prostate gland
• thyroid disease
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• high blood pressure
• heart disease
• diabetes
• cough that occurs with too much phlegm (mucus)

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not get better within 7 days or occur with fever
• cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed
• do not take more than 6 doses in any 24-hour period
• mL = milliliter
• only use the dose cup provided
• adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
• children under 12 years: do not use

Other information

• each 20 mL contains: sodium 9 mg
• use by expiration date on package
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Nighttime Cold & Flu

Active ingredients (in each 20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

• temporarily relieves these common cold and flu symptoms:
  • runny nose
  • headache
  • cough
  • sneezing
  • sore throat
  • minor aches and pains
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
• temporarily reduces fever
• controls cough to help you get to sleep

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 more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• rash
• blisters
• skin reddening

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.

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• liver disease
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis

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
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery

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
• new symptoms occur
• redness or swelling is present
• 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.

In case of overdose, get medical help or contact a Poison Control Center right away. 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 take more than directed
• do not take more than 4 doses in any 24-hour period
• mL = milliliter
• only use the dose cup provided
• adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
• children under 12 years: do not use

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

Principal Display Panel

NDC: 0363-4063-45

DAY & NIGHT PACK

 Walgreens

WALGREENS
PHARMACIST RECOMMENDED†

Compare to the active ingredients in
MAXIMUM STRENGTH MUCINEX FAST-MAX® Severe
Congestion & Cough & NIGHTSHIFT® Cold & Flu††

• Severe Congestion & Cough DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT GUAIFENESIN / EXPECTORANT PHENYLEPHRINE HCl / NASAL DECONGESTANT Maximum Strength Controls cough Relieves nasal & chest congestion Thins & loosens mucus 12 years & older:

  NIGHTTIME; Cold & Flu; ACETAMINOPHEN /; PAIN RELIEVER / FEVER REDUCER; DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT; TRIPROLIDINE HCl / ANTIHISTAMINE

  Multi-Symptom

  Relieves cough, fever, sore throat,; runny nose & sneezing; 12 years & older

2 – 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Do not take Severe Congestion
& Cough and Nighttime
Cold & Flu at the same time.

50844     REV0724A00406345

†Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.

††This product is not manufactured or
distributed by RB Health (US) LLC,
owner of the registered trademarks
MAXIMUM STRENGTH MUCINEX FAST-MAX®
and NIGHTSHIFT®.

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2025 Walgreen Co.

Walgreens 44-004063

INGREDIENTS AND APPEARANCE

SEVERE CONGESTION AND COUGH, COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-4063

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-4063-45	1 in 1 PACKAGE; Type 0: Not a Combination Product	10/23/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	177 mL
Part 2	1 BOTTLE, PLASTIC	177 mL

Part 1 of 2

SEVERE CONGESTION AND COUGH 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Item Code (Source)	NDC: 0363-8004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-8004-45	177 mL in 1 BOTTLE, PLASTIC; 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	10/04/2023

Part 2 of 2

COLD AND FLU  NIGHTTIME
acetaminophen, dextromethorphan hbr, triprolidine hcl solution

Product Information
Item Code (Source)	NDC: 0363-8063
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-8063-45	177 mL in 1 BOTTLE, PLASTIC; 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	10/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/23/2023

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(0363-4063) , pack(0363-4063)