TYLENOL® COLD HEAD CONGESTION SEVERE

TYLENOL COLD HEAD CONGESTION SEVERE - acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet, film coated 
Lil' Drug Store Products, Inc.

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TYLENOL®
COLD
HEAD CONGESTION
SEVERE

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

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

Do not use

Ask a doctor before use if you have

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

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

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: Taking more than the recommended dose (overdose) may cause liver damage. 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

Other information

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, shellac, sucralose, titanium dioxide

Questions or comments?

call 1-877-895-3665

Repackaged and distributed by:
Lil' Drug Store Products, Inc.,
1201 Continental Place NE, Cedar Rapids, IA 52402
1-877-507-6516 (M-F 8AM-4:30PM CST)
www.lildrugstore.com

PRINCIPAL DISPLAY PANEL - 4 CAPLETS Carton

See New Warnings Information

TYLENOL®
COLD
HEAD CONGESTION

SEVERE

Alleviates Head & Body Aches
Acetaminophen

Controls Cough
Dextromethorphan HBr

Thins & Loosens Mucus
Relieves Chest Congestion
Guaifenesin

Relieves Sinus Pressure &
Nasal Congestion
Phenylephrine HCl

Cool Burst
CAPLETS

4 CAPLETS

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 4 CAPLETS Carton

TYLENOL COLD HEAD CONGESTION SEVERE 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride   tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)66715-9715
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg
Guaifenesin (Guaifenesin) Guaifenesin200 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
croscarmellose sodium 
D&C yellow NO. 10 
aluminum oxide 
hydroxypropyl cellulose 
hypromellose 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycol 
shellac 
sucralose 
titanium dioxide 
Product Characteristics
ColorYELLOWScore no score
ShapeOVALSize19mm
FlavorImprint Code TY;Cold;Severe
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
166715-9715-11 POUCH In 1 CARTONcontains a POUCH
12 TABLET In 1 POUCHThis package is contained within the CARTON (66715-9715-1)
266715-9715-22 POUCH In 1 CARTONcontains a POUCH
22 TABLET In 1 POUCHThis package is contained within the CARTON (66715-9715-2)
366715-9715-33 POUCH In 1 CARTONcontains a POUCH
32 TABLET In 1 POUCHThis package is contained within the CARTON (66715-9715-3)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/10/2010

Labeler - Lil' Drug Store Products, Inc. (093103646)
Revised: 05/2010Lil' Drug Store Products, Inc.