ARAMARK MULTI-SYMPTOM COLD RELIEF- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet

Aramark Multi-Symptom Cold Relief by

Drug Labeling and Warnings

Aramark Multi-Symptom Cold Relief by is a Otc medication manufactured, distributed, or labeled by Western First Aid Safety DBA Aramark, ULTRA SEAL CORPORATION, Ultra Seal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INDICATIONS & USAGE

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

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

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

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 DOCTOR

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)

PREGNANCY

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

• 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 SAFETY INFORMATION

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 INGREDIENT

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

250 Tablet Box

2-Tablet Packet

res

INGREDIENTS AND APPEARANCE

ARAMARK MULTI-SYMPTOM COLD RELIEF 
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81238-0107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81238-0107-1	50 in 1 BOX	05/14/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 81238-0107-2	125 in 1 BOX	05/14/2021
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/14/2021

Labeler - Western First Aid Safety DBA Aramark (043861524)

Registrant - Western First Aid Safety DBA Aramark (043861524)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(81238-0107)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		944090448	manufacture(81238-0107)