DG HEALTH DAYTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule 
Dolgencorp 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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DayTime SEVERE Cold & Flu Relief

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purposes

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 softgels 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 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   • high blood pressure   • thyroid disease   • diabetes   • glaucoma   • trouble urinating due to enlarged prostate gland   • a sodium-restricted diet   • cough that occurs with too much phlegm (mucus)   • 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; taking sedatives or tranquilizers.

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.
Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only as directed  
• do not exceed 8 softgels per 24 hrs

 adults & children

 12 yrs & over

 2 softgels with water

 every 4 hours

 children 4 to under

 12 yrs

 ask a doctor
 children under 4 yrs do not use

Other information

• store at 20-25°C (68-77°F)   • protect from light, heat and moisture

Inactive ingredients

edible printing ink, FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

Call 1-888-577-8033 Monday - Friday 8am - 4pm EST

COMPARE TO VICKS® DAYQUIL® SEVERE COLD & FLU ACTIVE INGREDIENTS*

MULTI-SYMPTOM RELIEF

• Chest Congestion, Thins and Loosens Mucus

Antihistamine Free

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® and DayQuil™.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Distributed by:
Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816

Product of United Arab Emirates

Packaging

DG Health-285

DG HEALTH DAYTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-285
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColororangeScoreno score
ShapeOVAL (oblong) Size20mm
FlavorImprint Code 811
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-285-242 in 1 CARTON08/08/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/08/2023
Labeler - Dolgencorp Inc (068331990)

Revised: 8/2023
Document Id: ada163e1-58ca-44a9-a3ee-5ba7edae9e53
Set id: 91a66db7-ec48-4e62-bb5f-d6d6ddaf4cbe
Version: 1
Effective Time: 20230808
 
Dolgencorp Inc