DG HEALTH NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule

DG Health NightTime SEVERE Cold and Flu by

Drug Labeling and Warnings

DG Health NightTime SEVERE Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Dolgencorp Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms: 
nasal congestion sinus congestion & pressure  cough due to minor throat & bronchial irritation  cough to help you sleep  minor aches & pains  headache  fever  sore throat
runny nose & sneezing
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage

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  a sodium-restricted diet  trouble urinating due to enlarged prostate gland  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

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product
 do not use more than directed
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
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, 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

SPL UNCLASSIFIED SECTION

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

MULTI-SYMPTOM RELIEF

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 NyQuil™.

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

INGREDIENTS AND APPEARANCE

DG HEALTH NIGHTTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-286
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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
Color	green	Score	no score
Shape	OVAL (oblong)	Size	20mm
Flavor		Imprint Code	812
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-286-24	2 in 1 CARTON	08/08/2023
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/08/2023

Labeler - Dolgencorp Inc (068331990)