Aramark Fedrin by Western First Aid Safety DBA Aramark Aramark Fedrin

Aramark Fedrin by

Drug Labeling and Warnings

Aramark Fedrin by is a Otc medication manufactured, distributed, or labeled by Western First Aid Safety DBA Aramark. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARAMARK FEDRIN- acetaminophen, phenylephrine hcl 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 Fedrin

Drug Facts

Active Ingredient (in each tablet)
Acetaminophen 500 mg
Phenylephrine HLC 5 mg

Purpose
Acetaminophen ...................Pain reliever/fever reducer
Phenylephrine HCl ................Nasal decongestant

Uses:
Temporarily relieves these symptoms
associated with hay fever or other
respiratory allergies and the common cold:

headache                   sinus congestion and pressure
nasal congestion       minor aches and pains
                                    promotes sinus drainage
                                    temporarily reduces fever

Warnings:
Liver warning: This product contains acetaminophen.
The maximum daily dose of this product is 6 tablets
(3,000 mg acetaminophen) in 24 hours. 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 serve skin
reactions. Symptoms may include:
skin reddening blister rash
If a skin reaction occurs, stop use and seek medical
help right away

Do not use
with any other drug containing acetaminophen. 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 (MAOIs), 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.

Ask a doctor before use if you have:
liver disease
diabetes
heart disease
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate
  gland

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug Warfarin

When using this product do not exceed
recommended dose

Stop use and ask a doctor if:
nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets worse or lasts
more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
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
Overdose warning: 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.

Directions:
do not take more than directed (see
  overdose warning)
adults and children 12 years and over:
  take 2 tablet every 4 hours
  swallow whole; do not crush, chew or
  dissolve
  do not take more than 6 tablets in 24
     hours
children under 12 years: ask a doctor

Other information:
read all warnings and directions before use. Keep
carton. Store at 20-25°C (68-77°F) avoid excessive
heat above 40°C (104°F)

Inactive Ingredients:
Corn Starch, FD & C Blue #1 Lake, Microcystalline
Cellulose, Povidone, Sodium Starch Glycolate,
Stearic Acid, USP Purified Water

Package Labeling

aramark

100 TABLETS         Part # 91933B
PER BOX

FEDRIN
Pain Reliever/Nasal Decongestant

Temporary relief of headaches,
sinus pain, nasal and sinus congestion,
minor aches, pains, fever

MANUFACTURED FOR:

Aramark
Lenexa, KS 66219
(913) 269-9611

aramarkuniform.com

Retain carton for complete product information

100 Tablet Box

0140 100-Tab Box

250 Tablet Box

0140 250-Tab Box

2-Tablet Packet

0140 2-Tab Packet

res

ARAMARK FEDRIN 
acetaminophen, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81238-0140
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR33
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81238-0140-150 in 1 BOX05/07/202106/11/2021
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC: 81238-0140-2125 in 1 BOX05/07/202106/11/2021
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/07/202106/11/2021
Labeler - Western First Aid Safety DBA Aramark (043861524)
Registrant - Western First Aid Safety DBA Aramark (043861524)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(81238-0140)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION944090448manufacture(81238-0140)

Revised: 6/2021