DAYQUIL SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet 
Savings Distributors LLC

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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DayQuil Severe

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

• temporarily relieves common cold/flu symptoms: • nasal congestion

• sinus congestion & pressure • cough due to minor throat & bronchial irritation

• minor aches & pains • headache • fever • sore throat

• reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

• 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 8 caplets 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 Allert: 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 • high blood pressure

• thyroid disease • diabetes • trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough 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 use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion, 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.

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

• take only as directed • do not exceed 8 caplets in 24 hrs

adults & children 12 years & over 2 caplets with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Other information

each caplet contains: sodium 4 mg • do not exceed 25ºC

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions?

1-800-362-1683

Package Labeling

Package Label

DAYQUIL SEVERE 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-006(NDC:37000-811)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize19mm
FlavorImprint Code DQ
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73097-006-021 in 1 CARTON07/05/2019
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:73097-006-4020 in 1 CARTON07/05/2019
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:73097-006-5025 in 1 CARTON07/05/2019
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/2019
Labeler - Savings Distributors LLC (010527359)

Revised: 7/2019
Document Id: 8d6e93c1-81d3-d168-e053-2995a90a38c7
Set id: 8d6e81d0-34ad-7617-e053-2a95a90a7695
Version: 1
Effective Time: 20190710
 
Savings Distributors LLC