Smith bros night time cough and congestion powder, for solution

Smith bros night time cough & congestion


Active ingredients (in each packet)

Acetaminophen 500 mg
Dextromethorphan Hydrobromide 20 mg
Doxylamine Succinate 12.5 mg
Phenylephrine HCl 10 mg

Uses

  • Temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
    • cough
    • sore throat
    • sneezing
    • runny nose
  • temporarily reduces fever

Warnings

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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.


Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, nausea or vomiting, consult a doctor promptly.

Do Not Use To Sedate Children.

Directions

  • do not take more than recommended dose
  • take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor.

AGE
DOSE
children under 12 years
do not use
adults and children 12 years and over
one packet
  • dissolve 1 packet into 8oz. of hot water; sip while hot. Consume entire drink within 10 minutes.

Other information

  • each packet contains: 15 calories
  • store at room temperature. Avoid excessive heat.
  • Tamper Evident. Do not use if packet has been disturbed or torn.

Inactive ingredients:

Acesulfame Potassium, Citric Acid, FD and C Yellow No. 5, Flavors, Maltitol, Maltodextrin, Menthol, Silicon Dioxide, Sucralose.

Contains: FD and C Yellow No. 5 (tartrazine) as a color additive.

Ingredients and appearance - Product information

Smith bros night time cough and congestion powder, for solution- Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 76461-005
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 1
Doxylamine succinate ( UNII: V9BI9B5YI2)( Doxylamine - UNII: 95QB77JKPL ) 12.5 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Acesulfame potassium ( UNII: 23OV73Q5G9)
Citric acid monohydrate ( UNII: 2968PHW8QP)
Fd&c yellow no. 5 ( UNII: I753WB2F1M)
Maltitol ( UNII: D65DG142WK)
Maltodextrin ( UNII: 7CVR7L4A2D)
Menthol ( UNII: L7T10EIP3A)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Flavor HONEY (Honey Chamomile)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Universal Holdings I LLC( 028979475)

Establishment

Name ID/FEI Business Operations
Universal Holdings I LLC 028979475 manufacture( 76461-005)

Product labels