SMITH BROS NON-DROWSY MULTI-SYMPTOM COLD AND FLU- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride powder, for solution 
Universal Holdings I LLC

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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SMITH BROS NON-DROWSY MULTI-SYMPTOM COLD & FLU

SMITH BROS NON-DROWSY MULTI-SYMPTOM COLD & FLU


Active ingredients (in each packet)

Acetaminophen 650 mg
Dextromethorphan Hydrobromide 20 mg
Phenylephrine HCl 10 mg

Purpose

Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Uses

  • Temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
    • cough
    • sore throat
  • 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.

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients.
  • in children under 12 years

Ask a doctor before use if you have:

- liver disease, - hear disease, - high blood pressure, - thyroid disease, - diabetes, - glaucoma, - cough with excessive phlegm (mucus), - a breathing problem such as emphysema or chronic bronchitis, - difficulty in urination due to enlargement of prostate gland, - persistent or chronic cough such as occurs with smoking, asthma and 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 exceed recommended dosage
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • pain, cough, or nasal congestion gets worse or lasts for 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.

In case of overdose, get medical help or contract a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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.

PRODUCT LABELS

Honey Lemon Packet

SMITH BROS NON-DROWSY MULTI-SYMPTOM COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76461-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
Color    Score    
ShapeSize
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76461-004-088 in 1 BOX
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/201412/10/2015
Labeler - Universal Holdings I LLC (028979475)
Establishment
NameAddressID/FEIBusiness Operations
Amerilab Technologies, Inc884362070manufacture(76461-004)

Revised: 12/2015
 
Universal Holdings I LLC