ARAMARK MULTI-SYMPTOM COLD RELIEF- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet 
Western First Aid Safety DBA Aramark

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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Aramark Multi-Symptom Cold Relief

Drug Facts

Cold Relief Tablets
Active Ingredients (in each tablet)
Acetaminophen 325 mg
Guaifenesein 200 mg
Phenylephrine HCl 5 mg
Dextromethorphan HBr 15 mg

Purpose
Acetaminophen.....................Pain Reliever/Fever Reducer
Guaifenesein ........................Expectorant
Phenylephrine HCl ...............Decongestant
Dextromethorphan HBr. .......Antitussive

Uses: temporarily:
• relieves nasal congestion associated with sinusitis
• relieves nasal confestion due to the common cold, hay
  fever or other respiratory allergies
• relieves sinus congestion and pressure, helps
  decongest sinus openings and passages
• restores free breathing
• helps loosen phlegm (mucus) and thin bronchial
  secretions to rid the bronchial passages of
  bothersome mucus, drain bronchial tubes, and make
  coughs more productive
• temporarily suppresses cough due to minor throat
  and bronchial irritation associated with a cold or
  inhaled irritants
Temporarily relieves minor aches, pains and fever
associated with: • headache • backache • common
cold • muscular aches • toothache • menstrual cramps
o make coughs more productive

Warnings:
Liver Warning: This product containsacetaminophen.
Severe liver damage may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen
  (prescription or nonprescription)
• Ask a doctor or pharmacist before using with other
  drugs if you are not sure
• 3 or more alcoholic drinks every day while using
  this product.

Do not:
• use with any other product containing
  acetaminophen. This will provide more than the
  recommended dose (overdose) of acetaminophen
  and could cause serious health concerns.
• use more than the recommended dose
• for more than 10 days for pain unless directed by
  a doctor
• for more than 3 days for fever unless directed by a
  doctor
• when using this product do not exceed
  recommended dose 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 MAOI drug. If you do not
  know if your prescription drug contains an MAOI,
  consult a doctor or pharmacist before taking this
  product

Stop use and ask a doctor if:

• symptoms do not improve
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are
  accompanied by a fever
• cough persists for more than 1 week, tends
  to recur, or is
• accompanied by a fever, rash, or persistant headache.
• A persistant cough may be a sign of a serious
  condition

Ask a doctor before use if you have:
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the
  prostate gland
• persistent or chronic cough such as occurs with
  smoking,
• asthma, chronic bronchitis, or emphysema or where
  cough is
• accompanied by excessive phlegm (mucus)

If pregnant or breast-feedin baby, ask a health
professional before use.

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get
medical help or contact a Poison Control Center right
away. Prompt medical attention is critical for adults as
well as for children even if you do not notice any signs
or symptoms.

 Directions:
• Adults and children 12
  years of age and older:
Take 2 tablets every 6 to
8 hours as needed. Do
not exceed 8 tablets in 24
hours, or as directed by a
doctor.
• Children under 12 years:Consult a doctor.

Other Information:
Tamper evident. Do not use if packet is torn, cut or
opened Store at controlled room temperature 15° to
30°C (59° to 86° F) Avoid excessive heat and humidity

Inactive Ingredients:
Maltodextrin, Microcrystalline Cellulose, Povidone,
Sodium Starch Glycolate, Starch, Stearic Acid

Product Labeling

aramark

100 TABLETS            
PER BOX         Part # 82233B

Multi-Symptom
COLD RELIEF

Non-Pseudo Tablet
Decongestant

Temporary relief of minor
aches, pains, headache,
muscular aches, fever and
nasal congestion associated
with the common cold.

Compare active ingredient to:
DRISTAN Cold and Sinus®
Registered Trademark of Pfizer

Retain carton for complete product information

MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
866-362-2691

aramarkuniform.com

100 Tablet Box

0107-100ct tab Box

250 Tablet Box

0107-2 250ct tab Box

2-Tablet Packet

0107 2-tab packet

res

ARAMARK MULTI-SYMPTOM COLD RELIEF 
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-0107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81238-0107-150 in 1 BOX05/14/2021
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:81238-0107-2125 in 1 BOX05/14/2021
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/14/2021
Labeler - Western First Aid Safety DBA Aramark (043861524)
Registrant - Western First Aid Safety DBA Aramark (043861524)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(81238-0107)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation944090448manufacture(81238-0107)

Revised: 6/2021
Document Id: 86f89604-3018-413b-b417-eb58b9d35f95
Set id: 88aee6e7-16d1-413b-af8c-32aee050c724
Version: 1
Effective Time: 20210603
 
Western First Aid Safety DBA Aramark