NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled

NIGHTTIME SEVERE COLD AND FLU by

Drug Labeling and Warnings

NIGHTTIME SEVERE COLD AND FLU by is a Otc medication manufactured, distributed, or labeled by KROGER, TIME CAP LABS INC, MARKSANS PHARMA LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Acetaminophen
• PhenylephrineHCl,
• Doxylamine Succinate
• Dextromethorphan HBr

INACTIVE INGREDIENT

FD&C BLUE #1, GELATN, GLYCERIN, POLYETHYLENE GLYCOL, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SHELLAC, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE

PURPOSE

• Pain reliever/Fever reducer
• Cough suppressant
• Antihistamine
• Nasal decongestant

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

take only as directed
do not exceed 8 Softgels per 24 hours

• adults & children 12 yrs & over 2 Softgels with water every 6 hrs
• children 4 to under 12 yrs ask a doctor
• children under 4 yrs do not use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

WARNINGS

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

more than 8 Softgels in 24 hrs, 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NIGHTTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-626
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SHELLAC (UNII: 46N107B71O)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	BULLET	Size	16mm
Flavor		Imprint Code	72
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-626-08	8 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/29/2020

Labeler - KROGER (006999528)

Registrant - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(41226-626)