ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL- acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl capsule, liquid filled 
CVS PHARMACY, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Severe Non-Drowsy
Sinus Congestion and Cough Relief


Acetaminophen 325 mg each
Dextromethorphan hydrobromide 10 mg each
Phenylephrine hydrochloride 5 mg each

Severe
Sinus Congestion and Cough Relief

Acetaminophen 325 mg each
Dextromethorphan hydrobromide 10 mg each
Doxylamine succinate 6.25 mg each
Phenylephrine hydrochloride 5 mg each

Active ingredients

Severe Sinus Congestion and Cough Relief Day

(in each softgel)

Acetaminophen325 mg
Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves these symptoms due to cold and flu:

helps clear nasal passages and shrinks swollen membranes

temporarily reduces fever

Liver warning

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

Allergy alert

acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

If a skin or allergic 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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you have

taking the blood thinning drug warfarin.

when using this product

do not exceed recommended dosage

Stop use and ask a doctor if

If pregnant or breast-feeding

ask a health professional before use.

Keep out of the reach of children

In case of overdose, get medical help or contact 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 the recommended dose

adults & children under 12 years and over

children under 12 years

Other information

Inactive ingredients

allura red AC, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, glycerol, polyethylene glycol, povidone, propylene glycol, purified water, sorbital sorbitan solution, sunset yellow FCF

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

Active ingredients

Severe Sinus Congestion & Cough Relief Night

(in each softgel)

Acetaminophen325 mg
Dextromethorphan Hydrobromide10 mg
Doxylamine Succinate6.25 mg
Phenylephrine Hydrochloride5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to cold and flu:

helps clear nasal passages and shrinks swollen membranes
temporarily reduces fever

Liver warning

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

Allergy alert

acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

If a skin or allergic 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 to sedate children.

Do not use to sedate children.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding

ask a health professional before use.

Keep out of the reach of children

In case of overdose, get medical help or contact 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 the recommended dose

adults & children under 12 years and over

children under 12 years

Other information

Inactive ingredients

brilliant blue FCF, gelatin, glycerol, polyethylene glycol, povidone, propylene glycol, purified water, sorbital sorbitan solution, quilolline yellow WS.

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

20 count softgels

ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL 
acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
SORBITAN (UNII: 6O92ICV9RU)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorgreen, orange (534 (Daytime)) Scoreno score
ShapeOVAL (Orange (Daytime) Green (Nighttime)) Size20mm
FlavorImprint Code 534
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-303-0220 in 1 BLISTER PACK; Type 0: Not a Combination Product11/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/30/2017
Labeler - CVS PHARMACY, INC (062312574)

Revised: 10/2017
Document Id: 5bffd877-8097-5fc5-e053-2a91aa0a8ead
Set id: 5bffd877-8096-5fc5-e053-2a91aa0a8ead
Version: 1
Effective Time: 20171023
 
CVS PHARMACY, INC