WALGREEN HIGH BLOOD PRESSURE NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid

Walgreen High Blood Pressure Nighttime by

Drug Labeling and Warnings

Walgreen High Blood Pressure Nighttime by is a Otc medication manufactured, distributed, or labeled by WALGREENS CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• ▪ cough due to minor throat and bronchial irritation
• ▪ sore throat
• ▪ headache
• ▪ minor aches and pains
• ▪ fever
• ▪ runny nose and sneezing

Warnings

Liver warning

This product contains acetaminophen.
Severe liver damage may occur if you take

• ▪ more than 4 doses (30 mL each dose) in 24 hours, which is the maximum daily amount for this product
• ▪ 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.

Ask a doctor before use if you have

• ▪ liver disease
• ▪ glaucoma
• ▪ cough that occurs with too much phlegm (mucus)
• ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• ▪ trouble urinating due to 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

• ▪ 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

• ▪ 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 at 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.

Directions

• ▪ take only as directed
• ▪ use dose cup provided
• ▪ do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over:

  30 mL per dose every 6 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

• each 30 mL contains: sodium16 mg
• store at room temperature

Inactive ingredients

Anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions?

1-866-467-2748

SPL UNCLASSIFIED SECTION

Distributed by

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

Compare to the active ingredients in Vicks® NyQuil™ High Blood Pressure Cold & Flu*

NDC: 0363-6210-08

High Blood

Pressure

Nighttime

Cold & Flu

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat,

Minor Aches & Pains

Sneezing, Runny Nose

Cough

Sugar Free & No Added Alcohol

8 FL OZ (236 mL)

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® NyQuil™ High Blood Pressure Cold & Flu.

INGREDIENTS AND APPEARANCE

WALGREEN HIGH BLOOD PRESSURE NIGHTTIME  COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-6210-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/03/2023

Labeler - WALGREENS CO. (008965063)