COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Cold and Flu by

Drug Labeling and Warnings

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]

Active ingredients (in each 20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • stuffy nose
  • minor aches and pains
  • headache
  • cough
  • sore throat
  • sinus congestion and pressure
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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
• 3 or more alcoholic drinks every day while using this product
• with other drugs containing acetaminophen

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

• blisters
• rash
• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• new symptoms occur
• nervousness, dizziness, or sleeplessness occur
• fever gets worse or lasts more than 3 days
• 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 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 10 mg
• 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, disodium edetate, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal Display Panel 

0363-9042-45

Walgreens
WALGREENS
PHARMACIST RECOMMENDED†
Compare to the active ingredients
in Maximum Strength Mucinex®
FAST-MAX® Cold & Flu††

DAYTIME
Cold & Flu
ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT

Maximum Strength

Relieves headache, body pain,
  sore throat, fever, chest congestion,
  cough, nasal congestion,
  sinus congestion & pressure
12 years & older

6 FL OZ (177 mL)

†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 trademark
Maximum Strength Mucinex®
FAST-MAX® Cold & Flu.
DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2023 Walgreen Co.

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

Walgreens 44-042

INGREDIENTS AND APPEARANCE

COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9042
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
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
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 (MIXED)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9042-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/21/2023

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(0363-9042) , pack(0363-9042)