MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled 
FAMILY DOLLAR

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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633T FAMILY DOLLAR NIGHT MAXIMUM STRENGTH COLD AND FLU 55319-934-08

Active ingredients (in each SOFTGEL)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · nasal and sinus congestion

· temporarily reduces fever

Directions

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 softgels with water

every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.

· children under 12 years: do not use

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 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general 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.

8 CT

MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-934
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize16mm
FlavorImprint Code 72
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-934-088 in 1 BLISTER PACK; Type 0: Not a Combination Product08/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/02/2020
Labeler - FAMILY DOLLAR (024472631)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LTD925822975manufacture(55319-934)

Revised: 8/2020
Document Id: ad68bdc1-3246-2700-e053-2a95a90aa9e7
Set id: aa8f0465-1595-0b0f-e053-2a95a90a0081
Version: 3
Effective Time: 20200821
 
FAMILY DOLLAR