VICKS FORMULA 44DM NIGHTTIME COUGH AND COLD- acetaminophen, dextromethorphan hbr, chlorpheniramine maleate liquid

VICKS FORMULA 44DM by

Drug Labeling and Warnings

VICKS FORMULA 44DM by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Purpose

Pain reliever/Fever reducer
Antihistamine
Cough suppressant

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 in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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 is 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

take only as directed
only use the dose cup provided
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

Other information

• each 30 mL dose cup contains:sodium 25 mg
• store at no greater than 25°C and do not refrigerate

Inactive ingredients

citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-362-1683

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TAMPER EVIDENT: Do not use if printed shrinkband is broken or missing.

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DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

VICKS ®

FORMULA 44™DM

Nighttime COUGH & COLD

Acetaminophen

Dextromethorphan HBr,

Chlorpheniramine Maleate

Fever, Minor Aches & Pains

Cough

Sneezing, Runny Nose
12 FL OZ (354 mL)

INGREDIENTS AND APPEARANCE

VICKS FORMULA 44DM  NIGHTTIME COUGH AND COLD
acetaminophen, dextromethorphan hbr, chlorpheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-811
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 15 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-811-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/25/2021

Labeler - Procter & Gamble Manufacturing Company (004238200)