CVS OVERNIGHT COLD AND FLU CLEAR AND COOL- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution

CVS Overnight Cold and Flu Clear and Cool by

Drug Labeling and Warnings

CVS Overnight Cold and Flu Clear and Cool by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Phenylephrine HCl 10 mg	Nasal decongestant
Triprolidine HCl 2.5 mg	Antihistamine

Uses

• temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • sinus congestion and pressure
  • 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 4000 mg in 24 hours, which is the maximum daily amount
• ▪ 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 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
• ▪ heart disease
• ▪ diabetes
• ▪ high blood pressure
• ▪ thyroid disease
• ▪ glaucoma
• ▪ trouble urinating due to an enlarged prostate gland
• ▪ a breathing problem such as emphysema or chronic bronchitis
• ▪ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• ▪ cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• ▪ taking the blood thinning drug warfarin
• ▪ taking sedatives or tranquilizers

When using this product

• ▪ do not use more than directed
• ▪ excitability may occur, especially in children
• marked drowsiness may occur
• ▪ alcohol, sedatives, and tranquilizers may increase drowsiness
• ▪ avoid alcoholic drinks
• ▪ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• ▪ nervousness, dizziness, or sleeplessness occur
• ▪ pain, nasal decongestion, 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 fever, 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

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 (see Overdose warning)
• ▪ do not take more than 4 doses in any 24-hour period
• ▪ measure only with dosing cup provided
• ▪ do not use dosing cup with other products
• ▪ dose as follows or as directed by a doctor
• ▪ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
• ▪ children under 12 years of age: do not use

Other information

• each 20 mL contains:sodium 10 mg
• store at room temperature
• do not refrigerate

Inactive ingredients

anhydrous citric acid, ascorbic acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose and xanthan gum

Questions?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

NDC: 69842-966-06

Overnight Cold & Flu Clear & Cool

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
Triprolidine HCl – Antihistamine

Night Time
Relief for a Better Morning

• Cough
• Fever
• Sore Throat
• Runny Nose
• Sneezing
• Nasal Congestion

6 FL OZ (180 mL)
FOR AGES 12+

Tamper evident: do not use if printed seal under cap is broken or missing.

•   Maximum Strength per 4-hour dose

Distributed by:

*This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu Clear & Cool.

INGREDIENTS AND APPEARANCE

CVS OVERNIGHT COLD AND FLU CLEAR AND COOL 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-966
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 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)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
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)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-966-06	180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/31/2020

Labeler - CVS PHARMACY, INC (062312574)